Project of

Law politics & society

AD-BA 2

BY:
Shoaib Hassan
Asad Nazeer
Rehan Sheikh
Haseeb Sajid
Daniyal Akhtab
Prime Pharmaceuticals
Company Limited
Creating a public company in the pharmaceutical industry
involves specific steps. Here's an example of the steps
involved in creating a public pharmaceutical company:

1. Choose a corporate structure: Our Company is named

“Prime Pharmaceuticals CO. LTD.” is a public limited company
which bases clearly on a hierarchical structure of running a
business. Hierarchical structures include:
Board of Directors
The board of directors reports to the shareholders.
The board's tasks include:
• Making sure managers are effective
• Keeping the chief executive officer (CEO) on track
• Reviewing the company's plans, budgets, and goals
• Ensuring the business follows the law
• Writing bylaws
• Creating committees
• Protecting shareholders
• Holding annual meetings
The board can be one or many people with diverse experiences.
Shareholders elect board members. The company's bylaws will
say how many members the board needs. Usually, the board of
directors has an odd number of members to avoid tied votes.
Members' personal assets are separate from business assets.
However, they are still responsible for business debts. They are
also responsible for the corporation, its officers, agents,
employees, and subsidiaries.
Directors may include:
• Chairman: This person leads the business and is responsible for
the board's actions. They work with top officers. He or she acts as
the public face of the company. Usually, the chairman starts as a
board member.
• Inside Directors: These people are in charge of budgets. They
may be shareholders or top managers. Sometimes they are called
executive directors.
• Outside Directors: These people have the same responsibilities
as inside directors, but they are not officers or managers. They
offer unbiased opinions.
Corporate Officers
Corporate officers are chosen by the board. They are also called
upper management. Officers handle day-to-day tasks. They look
out for the company's interests.
There are four kinds of officers:
• President or CEO: This officer enforces policy, signs documents,
and works with the board of directors. They may also be the
president.
CEOs enforce decisions.
• Vice President or Chief Operations Officer
(COO): This officer is a senior executive. VPs replace the
president if he or she can no longer act as president. COOs run
the daily business, marketing, production, sales, and staff.
• Treasurer or Chief Financial Officer (CFO):
This officer is in charge of finances. The CFO writes budgets,
tracks spending, and writes reports. Most CFOs give reports to
the board, the Securities and Exchange Commission (SEC), and
other agencies.
• Secretary: This officer keeps records, minutes, and books.
Shareholders
Shareholders own the company. They don't typically take part in
daily business. Different kinds of corporations have different
numbers of shareholders.
S corporations, or s-corps, usually have fewer than
100. C corporations, or C-corps, may have many more than that.
A corporation may have several shareholders. Each owns a part
of the company. Owning more of the business gives a
shareholder more power.
These people own common stock shares. They get a return from
the company in the form of profits.
Shareholders are not personally liable for the company.
Shareholders help make decisions. Those who own more shares
have more interest in the company.
While a corporation's owners are usually its first shareholders,
larger companies can have many public shareholders.
Shareholders can vote on:
• Members of the board of directors
• Changing bylaws or the Articles of Incorporation
• Dissolving or merging the company with another
• Disposing of assets
2. Memorandum of Association:
Prime Pharmaceuticals Co. LTD.
MEMORANDUM OF ASSOCIATION

1. Prime Pharmaceuticals Co. LTD.

2. Block E North, Naseerabad, Peshawar Road, Rawalpindi,

Punjab, Pakistan.

3. The objects for which the Company is established are as

follows:

a. To carry on the business of manufacturing, producing,

processing, importing, exporting, buying, selling, distributing,
marketing, and dealing in all types of pharmaceutical and
healthcare products, including medicines, drugs, vaccines,
medical devices, and related products.

b. To establish, own, and operate pharmaceutical

manufacturing facilities, research and development laboratories,
and medical testing facilities.

c. To acquire, lease, own, and manage intellectual property

rights, including patents, trademarks, copyrights, and know-how
associated with pharmaceutical products.
 d. To enter into collaborations, joint ventures, partnerships, or
other forms of cooperation with local and international
pharmaceutical companies, research institutions, and healthcare
providers for the development, production, and marketing of
pharmaceutical products.

e. To engage in the research, development, and

commercialization of innovative pharmaceutical formulations, drug
delivery systems, and medical technologies.

f. To conduct clinical trials, obtain necessary regulatory

approvals, and comply with all applicable laws and regulations
regarding the manufacturing, marketing, and distribution of
pharmaceutical products.

g. To provide healthcare and consultancy services, including

medical advice, diagnosis, treatment, and post-treatment support.

h. To organize and conduct seminars, conferences, workshops,

and training programs related to pharmaceutical and healthcare
subjects.

i. To invest in or acquire shares, stocks, bonds, debentures, or

other securities issued by other pharmaceutical companies or
companies operating in related industries.
 j. To establish and manage quality control standards, adhere to
ethical practices, and contribute to the promotion of public health
and well-being.

4. The liability of the members is limited.

5. The authorized share capital of the Company is [Amount in

Currency] divided into [Number of Shares] shares of [Currency
and Denomination] each.

Witnessed by:

Name: Prime Pharmaceuticals Co. LTD.

Address: Block E North, Naseerabad, Peshawar Road,
Rawalpindi, Punjab, Pakistan.
Occupation: pharmaceuticals
Date: 22/07/2023
2. Articles of Incorporation:
ARTICLES OF ASSOCIATION OF
Prime Pharmaceutical Co. LTD.
-Article 1.
- (Name).
The company, incorporated as a public limited liability company,
shall carry out its
business under the name [Prime Pharmaceutical Co. LTD.].
-Article 2 -
- (Registered Office)-
1. The company's registered office is located at [Block E North,
Naseerabad, Peshawar Road, Rawalpindi, Punjab, Pakistan.] and
maybe
transferred to other location within the national territory by
decision of the board of
2. The board of directors may open, close or transfer branches,
agencies or
representation offices of the company, within the national territory
or abroad,
regardless of a general meeting resolution
-Article 3.
-(Scope)
1. The company's purpose is to carry on the business of
manufacturing, producing, processing, importing, exporting,
buying, selling, distributing, marketing, and dealing in all types of
pharmaceutical and healthcare products, including medicines,
drugs, vaccines, medical devices, and related products.].
2. The company may also purchase and sell shares in companies
with the same or
different corporate purposes, in companies governed by specific
regulations, in
companies with limited or unlimited liability, as well as enter into
association with other legal entities new companies, joint-
ventures, and also, provide or participate in any term of the
association, temporary or permanent, between companies and/or
entities of other
nature
-Article 4.
-(Duration)
The company shall carry out its business indefinitely from the date
of its incorporation.
-Article 5.
- (Share capital)
1. The fully-paid share capital is 2 billion PKR corresponding to
100 million shares, with a nominal value of 20 PKR each. -
2. All the shares are nominative shares.
3. The certificates representing the shares or the bonds, either
definitive or temporary, shall be signed by two directors of the
company or by one proxy vested with the necessary powers. The
signature of the Directors may be put by chancellery duly
authorized by them.
-Article 6.
(Issue of bonds)
The company may issue bonds in accordance with the relevant
legal provisions and
under the terms and conditions set forth by the general meeting.
-Article 7.
- (Transfer of shares) •
1. The transfer of shares is always subject to the company's
consent, which will be provided as follow:
a) The shareholder who wishes to transfer the shares that he
holds must apply for
approval by the company by letter addressed to the board of
directors of the company, referring to all the elements and transfer
characteristics;
b) Within thirty days of the reception of the notice mentioned in
the previous paragraph, a board meeting should be held to
resolve the request for consent; -
c) If the board of directors does not resolve the request for
consent within the period specified in the preceding paragraph,
the transmission is deemed cleared;
d) If the company refuses to consent, it shall notify in writing the
shareholder within fifteen days after the board meeting, stating
the grounds for refusal and presenting a proposal for acquisition
or redemption of the shares in the terms and conditions of
the deal presented to the company by the shareholder wishing to
transfer the shares;
e) After receiving one of the above proposals, the relevant
shareholder has fifteen days to either accept or reject the
proposal; should it refuse the proposal or say nothing within such
deadline,
3. SECP filings: As a public company, this includes a detailed
prospectus outlining the pharmaceutical company's business,
financials, product pipeline, clinical trials, and regulatory
compliance.
The following are the steps for SECP filing for a pharmaceutical
company in Pakistan:
1. Obtain Digital Signature Certificate (DSC): We have obtained a
digital signature certificate (DSC) from an SECP-approved
certifying authority. The DSC has signed and submitted
documents electronically.

2. Register the company: In order to register the pharmaceutical

company with the SECP, we have submitted the Memorandum
and Articles of Association, Form 1 (Declaration of Compliance),
and Form 21 (Notice of Situation of Registered Office of the
Company) along with the required fees.

3. Obtain National Tax Number (NTN): The NTN number of our

pharmaceutical company is NTN # 2666637‐5

4. Register with the Drug Regulatory Authority of Pakistan

(DRAP): We are registered with the DRAP and obtain a Drug
Manufacturing License (DML) or Drug Import License (DIL)
depending on their business activities.

5. Register with the Pakistan Medical Commission (PMC):

Pharmaceutical companies that manufacture or import medical
devices are required to register with the PMC.

6. Register with the Pakistan Standards and Quality Control

Authority (PSQCA): Pharmaceutical companies are required to
register with the PSQCA and obtain a Certificate of Conformity
(CoC) for their products.
7. Register with the Pakistan Engineering Council (PEC):
Pharmaceutical companies that engage in engineering activities
are required to register with the PEC.

8. File annual returns: Pharmaceutical companies are required to

file annual returns with the SECP and maintain proper books of
accounts.

9. Comply with other regulatory requirements: Pharmaceutical

companies are subject to various other regulatory requirements,
including those related to labor laws, environmental regulations,
and intellectual property rights.

Complying with SECP requirements is essential for

pharmaceutical companies in Pakistan to operate legally and
avoid penalties. It is recommended that companies seek the
assistance of legal and financial experts to ensure that they are
meeting all requirements.

4. Board of Directors: We have a board of directors with

appropriate expertise in pharmaceuticals, research, development,
and regulatory compliance. They consider implementing
committees focused on scientific review, clinical trials, and risk
assessment.
Our company's board of directors is chosen by shareholders, and
its primary job is to look out for shareholders' interests. In fact,
directors are legally required to put shareholders' interests ahead
of their own. In general, the role of the board is to provide high-
level oversight of corporate activities and performance, while
some individual board members may take on more involved or
activist roles.
Directors' actions can have a critical impact on a company's
profitability. As such, it's important for investors to understand the
role of corporate boards and their own role in electing them.
Once a year, during proxy season, shareholders have an
opportunity to vote on at least some members of the board of a
public company. This is your chance to have a say over who
leads the company. You'll want to scrutinize the proxy materials.
Take a close look at who has been nominated to serve on the
board, and ask questions before you make your decision.
Duties of directors
The board of directors of our company has a number of important
duties, including:

1. Setting the company's strategic direction: The board of

directors is responsible for setting the company's strategic
direction and ensuring that the company is moving in the right
direction.

2. Overseeing the company's operations: The board of directors is

responsible for overseeing the company's operations and
ensuring that the company is operating effectively and efficiently.
3. Monitoring financial performance: The board of directors is
responsible for monitoring the company's financial performance
and ensuring that the company is meeting its financial goals.

4. Providing guidance and support to the CEO: The board of

directors is responsible for providing guidance and support to the
CEO, and ensuring that the CEO is leading the company
effectively.

5. Ensuring compliance with laws and regulations: The board of

directors is responsible for ensuring that the company is
complying with all relevant laws and regulations.

6. Managing risk: The board of directors is responsible for

managing risk and ensuring that the company is taking
appropriate steps to mitigate risk.

7. Representing shareholders: The board of directors is

responsible for representing the interests of the company's
shareholders and ensuring that their interests are being taken into
account.

Overall, the board of directors of our company plays a critical role

in ensuring that the company is successful and that it operates
ethically and responsibly.
The Board framework for the operations.
The board is fully committed to its role in ensuring quality
compliance and effective risk management. Our Board comprises
a balance of Executive and Non-Executive Directors who bring
years of experience in analytical chemistry and the
pharmaceutical industry. The Board plays a vital role in corporate
accountability by bringing in independent judgment to issues of
strategy, performance, and risk management.
The Board receives regular reports from:
• COO (on Management, Business and
Quality Compliance).
COVID - 19
• CFS
• Director HR
• The Company’s independent auditor
• Business development
o Chief Quality Operations
• Scientific Advisory Board
5. Shareholder agreements: Shareholder agreements specify
the rights and obligations of the company’s shareholders. Include
provisions on proprietary rights to intellectual property, restrictions
on share transfers, and handling of regulatory issues.
The undersigned:
Prime Pharmaceuticals CO. LTD.
with paid-in capital of
the trade register number
registration number
, represented by its Director
(further companies)
the headquarters
_Hereinafter
The Shareholders or the Parties
THE FOLLOWING WAS DISCUSSED AND AGREED:
The Parties of the present pact have constituted a name of which
they are the founding Shareholders.
Organizing joint participation in trade fairs and exhibitions and
launching joint promotional
Conducting market research and research on the economic
environment;
Researching logistics;
Creating, promoting, and managing a website as well as its
development towards e-
commerce
Creating training programs;
Undertaking lobbying activities;
Creating a review of industry-related publications:
Creating networks;
Studying the possibilities of joint purchase and sales;
Studying jointly the logistics of traditional sales and joint orders as
well as all related activities.
2. Direct or indirect participation of the consortium in all industrial,
business, or financial operations or activities in
Pakistan or abroad that are linked directly or
indirect to the corporate object.
- Having taken the nature of the consortium's activities and its
founding Shareholders into
consideration. the Parties have defined the rules regulating their
relations.
'Adapted from UNIDO (2002).
HAVING STATED THIS, THE FOLLOWING HAS BEEN
AGREED:
1. DEFINITIONS
The terms used in this Shareholders Agreement which are
capitalized have the following meaning.
«Shareholders or Parties»: refers to the undersigned as well as to
the persons that subsequently adhere to the present Agreement.
«Representative»: refers to a person appointed by a Shareholder.
At any moment, a new Representative may be designated using a
simple notification to the chairman of the Board by registered
letter with acknowledgment of receipt.
«Transfer» refers to all legal operations with the aim and/or the
effect of transferring property
directly or indirectly such as a sale. trade. donation. liquidation.
succession. contribution Or
Transmission
«Title» refers to all movable property granting, directly or
indirectly, right to the capital of the
2. CAPITAL STRUCTURE:
The company's capital, initially amounting to
is entirely registered and paid up.
The capital is distributed equally among the
_Shareholders. This distribution must be upheld
in case of the increase or decrease of capital except for the failure
of a Shareholder.
3. CAPITAL INCREASE:
In case a Shareholder does not participate in the increase o
capital agreed upon by the Extraordinary Meeting. and after a
formal notice from the chairman of the Board. the general
The meeting may exclude the Shareholder who has failed to meet
his obligations.
4. BOARD OF DIRECTORS:
The Board of Directors is made up of a Representative of each
Shareholder.
5. CHAIRMAN OF THE BOARD - EXECUTIVE DIRECTOR:
The Chairman of the Board will be chosen among the
Shareholders for a period of one year.
Each year, the Board of Directors will designate a new Chairman
of the Board.
The Executive Director of the consortium will be chosen
externally. In exceptional cases. one of the Shareholders may be
designated for this position by the Board of Directors for a limited
period.
A deputy Executive Director can be chosen externally. In
exceptional cases, one of the Shareholders may be designated
for this position by the Board of Directors for a limited period.
5. President
The President will be chosen among the Shareholders. His
mandate is for a period of three years with the possibility of
extension. Each year, the Board of Directors will validate the
extension
of his mandate
6. NON COMPETITION:
Bach Shareholder commits to refrain from competing directly or
indirectly with another
Shareholder of the consortium while he is a Shareholder of the
consortium.
7. DEVELOPMENT AND PROMOTION OF THE CONSORTIUM:
Each Shareholder commits to doing everything within his power to
develop and promote the consortium on all levels
8. TRANSFER OF SHARES - NEW SHAREHOLDERS:
The Shareholders may not sell their shares before a period of five
(5) years has elapsed from the signing of this Agreement.
The sale of shares to a third non-competing Party must be
authorized by Shareholders representing three-fourths of the
consortium’s capital.
No new participation of a direct or indirect competitor in the
consortium, be it through the purchase of Shares or an increase
in the capital. will be authorized without the unanimous
Agreement of the Shareholders authorized.
The consortium may nevertheless accent new members that are
not Shareholders but may make
use of certain services rendered by the consortium
9. DURATION
The present Agreement will come into force starting on the day it
is signed and will be effective throughout the life of the
consortium.
10. ADHESION TO THE SHAREHOLDERS' AGREEMENT
No Shareholder may sell his Titles, including in cases where the
Transfer has been authorized
by the other shareholders or is affected by the present provisions.
without that, the beneficiary of this Transfer has signed the
present Shareholders' Agreement.
11. CONFIDENTIALITY
The Parties will agree on the content and the means of the
information they wish to convey to third parties concerning the
present Agreement and its implementation. The Party/the Parties
taking the initiative, without the consent of the other Parties, to
reveal the existence of the present document. will bear the
consequences
12. LAW AND JURISDICTION
The present contract will be subject to
Pakistan’s law.
The Shareholders agree that all disputes which may arise about
the interpretation and the implementation of the present contract
will be submitted to an arbitrator chosen by common agreement
before being submitted to the court
This arbitrator will attempt to settle the dispute submitted to him
by finding an amicable agreement within three (3) months of the
submission of the case.
In the case an amicable agreement cannot be found within the
timeframe specified above, as well as that an arbitrator cannot be
designated, the Shareholders agree to submit the dispute to three
arbitrators designated and ruled by the
Pakistan’s arbitration
Each Party will assume his arbitration expenses.
The judgment is binding and irrevocable.
13. INVALIDITY OF AN ARRANGEMENT
The invalidity of one of the obligations resulting from the present
document, for whatever reason, will not affect the validity of the
other obligations resulting from the Shareholders Agreement,
whatever they may be, for as long as the Shareholders'
Agreement stays in force.
14. NON-RENUNCIATION OF BENEFITS
The partial or total lack of exercising any one of the agreements
resulting from this contract by
one of the Parties does not imply renouncing the benefits of this
right or of any other right resulting from the present Agreement in
the future
15. SUCCESSORS
The arrangements of the present Agreement will benefit and
apply to the heirs, successors, and entitled parties of the
undersigned. The legal representatives, successors, heirs, and
entitled parties of the undersigned are jointly held to respect the
present Agreement.
IN WITNESS THAT THE PARTIES HAVE SIGNED TEN
ORIGINAL COPIES OF THE PRESENT AGREEMENT
(Rawalpindi, 22/07/23)
Represented by its Director Genera
(Prime Pharmaceuticals CO. LTD.)

6. Stock exchange listing:

Listing On Pakistan Stock Exchange

Road Map to Progress

An initial public offering (IPO) is the process where a company
issues a stake of its ownership to the public for the first time.

Investors who wish to gain ownership in a company subscribe to

the company’s shares.

Privilege of Listing the Company

why should we list the company on Pakistan Stock Exchange

(PSX)?

Raise Long-Term Low-cost Capital!

1 Growth and expansion needs.

2 Invest or carry out merger & acquisition plans.
3 Invest in new projects.
4 Enhance current capacity.
5  Diversify business.
6  Meets working capital requirements.
 Inclusion in Indices :

The PSX has several indices like KSE 100, a benchmark used
by investors all around the world to measure Pakistan’s
performance. The listing will give you the chance to be included
in these indices, providing you with global recognition.

Inexpensive Financing :

Money raised through offering your company’s share on the

bourse is relatively inexpensive, especially in a rising interest
rate environment, helping organizations reduce their
dependence on costly long-term and short-term loans.

Enhances Company’s Public Profile:

IPOs add a level of prestige to a Company.

IPOs can be used as a branding and marketing tool as they
attract media interest, attention and scrutiny.
Listed companies on the Exchange are regarded as Industry
leaders in their respective sectors.
Tax Credit:
20% on the tax payable in the first year of listing.
20% on the tax payable in the subsequent first tax year of listing.
10% on the tax payable in the following two tax years
respectively.

Improved Relations with Bankers and Suppliers:

A listed company has to disclose and disseminate all material and

price sensitive financial information which adds to:
The business transparency.
Improved relations with Bankers, lenders and clients.

Higher Valuation:

By going public, all stakeholders involved use fair valuation of the

company by the market which is generally higher than the book
value, outlining the true worth of an organization.

Requirement for Listing the Company

What is the Eligibility Criteria?

Main Board: Minimum post-issue paid-up capital of Rs.200
Million.
SME BOARD: Post-issue paid-up capital between Rs.25 - 200
Million.

What are the mandatory requirements?

Financial Statements

Must prepare periodic Financial statements.

Must audit statements by QCR (Quality Control Review) rated
chartered accountants.
Must publish on the website.

SME Website

Must contain basic business information.

Must contain a prospectus.
Must post annual, half-year quarterly accounts.

Operational Requirements

Must be in business for at least three years.

Must be profitable for at least two preceding years before getting
listed.

Annual Listing Fee

Initial Listing Fees:

One-tenth of 1% of Paid Up Capital.

Capped at PKR 1.5 Million.

Annual Listing Fees:

Annual Rate for FY 2018-19.

Annual Rate for FY 2019-20.
Capped at PKR 3 Million.

Listing Procedure
How can you get your company listed on the Exchange?
Your Company appoints a “Consultant” and completes the
submission of all documents.
Initial review of your Company and necessary due diligence to
ensure adequate disclosures in the prospectus.
On behalf of the Exchange, the PSX Listing Committee allows
approval of your listing application.
SECP gives approval of your prospectus.
Public offer is held through fixed price or book building method.

Your Company is formally listed on the Exchange.

7. Public announcements and investor communication:

Dear valued stakeholders,

We are pleased to update you on the latest developments at our

pharmaceutical company, Prime Pharmaceutical CO. LTD. With a
strong commitment to enhancing global healthcare solutions, we
are dedicated to delivering groundbreaking treatments and
medicines that improve the lives of patients worldwide.

New Research and Development Initiatives:

We are proud to announce significant progress in our research
and development efforts. Our talented team of scientists and
researchers continues to drive innovation and make
advancements in various therapeutic areas, including oncology,
cardiovascular diseases, neurological disorders, and rare genetic
conditions. Exciting breakthroughs have been achieved in the
discovery and development of potential new therapies, bringing
hope to patients in need.
FDA Approval and Clinical Trials:
We are thrilled to share that our flagship product, [Product Name],
has successfully obtained regulatory approval from the U.S. Food
and Drug Administration (FDA) following rigorous clinical trials.
This milestone underscores our unwavering commitment to
safety, efficacy, and quality, fulfilling our promise to provide safe
and effective treatments to patients. Furthermore, we are actively
engaging in extensive clinical trials for several other promising
drug candidates, as we strive to expand the scope of our
therapeutic offerings.

Sustainability and Corporate Responsibility:

At [Company Name], we understand the importance of corporate
responsibility and sustainability in the pharmaceutical industry.
Guided by our commitment to making a positive impact on
society, we are actively pursuing initiatives to improve access to
affordable medicines for underprivileged communities.
Additionally, we are continuously exploring and implementing
environmentally friendly practices across our operations, aiming
to reduce our ecological footprint and contribute to a healthier
planet.

Investor Relations:
To our esteemed investors, we would like to express our gratitude
for your continued support and confidence in our business. We
remain committed to providing transparent and timely
communication regarding our financial performance, strategic
plans, and upcoming milestones. As we navigate the dynamic
global healthcare landscape, we recognize the significance of
maintaining a strong and mutually beneficial relationship with our
valued shareholders, ensuring a successful future together.

Upcoming Events:
We are excited to invite you to our upcoming Investor Day, where
we will provide detailed insights into our current pipeline,
upcoming launches, and key business strategies. This event will
be an excellent opportunity for you to engage directly with our
management team and gain a comprehensive understanding of
our future growth prospects. Please stay tuned for further details
and save the date.

Conclusion:
We are incredibly proud of our accomplishments as a
pharmaceutical company dedicated to improving the health and
well-being of patients around the world. With our unwavering
commitment to research, development, and sustainability, we are
confident in our ability to bring life-changing treatments and
innovations to market.

Thank you for your continued support and trust as we strive to

make a meaningful difference in the lives of patients and
contribute to the advancement of global healthcare. Together, we
can create a healthier and brighter future for all.

Sincerely,
[Prime Pharmaceuticals CO. LTD.]

8. Ongoing regulatory compliance: After going public, we

ensured compliance with various ongoing legal and regulatory
requirements, including financial reporting, disclosures of adverse
events, approvals, and inspections, and compliance with
healthcare laws like the Foreign Corrupt Practices Act (FCPA)
WHO.
We as a Pharmaceutical company operating in Pakistan are
subject to a wide range of regulatory requirements, including
those related to drug development, manufacturing, marketing, and
sales. The regulatory framework for pharmaceutical companies in
Pakistan is overseen by the Drug Regulatory Authority of Pakistan
(DRAP).

Some of the key areas of regulatory compliance for our

pharmaceutical company in Pakistan include:

1. Clinical trials: Pharmaceutical companies must conduct clinical

trials to demonstrate the safety and efficacy of their drugs. These
trials must be conducted by regulatory requirements, including
obtaining informed consent from participants, ensuring the safety
of participants, and maintaining accurate records.

2. Manufacturing: Pharmaceutical companies must comply with

good manufacturing practices (GMP) to ensure that their products
are consistently produced and controlled to meet quality
standards. This includes maintaining appropriate facilities,
equipment, and processes, and conducting regular quality control
testing.

3. Marketing and sales: Pharmaceutical companies must comply

with regulations related to the marketing and sales of their
products, including restrictions on advertising, promotion, and
distribution. This includes complying with labeling and packaging
requirements, and ensuring that all marketing materials are
truthful and not misleading.

4. Pharmacovigilance: Pharmaceutical companies must monitor

the safety of their products and report adverse events to
regulatory authorities. This includes maintaining a system for
tracking and reporting adverse events and conducting regular
safety reviews.

5. Intellectual property: Pharmaceutical companies must protect

their intellectual property, including patents, trademarks, and
trade secrets. This includes enforcing their rights against
infringement and unauthorized use.

6. Environmental regulations: Pharmaceutical companies must

comply with environmental regulations related to the disposal of
hazardous waste, emissions, and other environmental impacts.

Ongoing regulatory compliance is a complex and constantly

evolving process for pharmaceutical companies in Pakistan. Our
companies must stay up to date on changes in regulations and
guidelines, and work closely with regulatory authorities such as
DRAP to ensure that they are meeting all requirements.