FDA REGULATORY CONSULTING

PRODUCT REGISTRATION (CPR) -

PREPACKAGED FOOD
ABOUT US

At iAQount, we're your trusted partner for

business needs in the Philippines. Since 2019,
we've assisted over 500 clients with services
ranging from business registrations and permits
to FDA consulting, product registration, GMP
training, and accounting and tax filing.

Our commitment is to simplify and streamline

complex processes, ensuring your
entrepreneurial journey in the Philippines is as
smooth and efficient as possible. Choose
iAQount for reliable and timely support, and let's
work together to build your business success.
 LEADING CLIENTS TESTIMONIALS

“iAQount played an invaluable role in helping Unilever Philippines Inc. achieve GMP
compliance and secure FDA LTO as a Cosmetic Manufacturer at our Cavite Plant
Site. Their expertise and commitment were instrumental in streamlining the
process, ensuring regulatory compliance, and making this accomplishment a
reality. We highly recommend iAQount as a trusted partner for regulatory
services.”

-Unilever Philippines Inc.

iAQount was a big help in getting our business permits and registrations done in
the Philippines. They made the process easy, and we stayed in line with all the
local rules. We'd recommend iAQount for anyone who needs help with regulatory
stuff.

-Realme Philippines Inc.

 CLIENT TESTIMONIALS

Even though we faced some initial challenges, iAQount never stopped helping us
achieve compliance and get our brand approved by the FDA in the Philippines.
They made it easy for us, and thanks to them, we're expanding our business
across Asia. We truly appreciate their excellent service!

-Life Force Asia International

iAQount made it possible for Bee Choo Origins to get approval for our organic
skincare products and market them legally in the Philippines. They helped us
navigate the process smoothly, and we're now able to reach our customers the
right way. We're grateful for iAQount's support and expertise.

-Bee Choo Origins

SERVICES

Business Registration Services (for Sole Proprietors, Partnerships

and Corporations)

FDA Consulting and Product Registrations

GMP and GDP Consulting and Training for Food/Cosmetics/Pharmaceuticals

and Medical Device Manufacturers

Regulatory Documentation Services such as preparation of CAPA,

Standard Operating Procedures, Risk Management Plan, Site Master File etc.

Accounting and Tax Filing

Other Regulatory and Management Consultancy Services

SCOPE

We assess the client's documents and conduct a gap analysis to identify

areas needing improvement or compliance.

iAQount ensures thorough evaluation of the documents before submission

to the FDA to minimize deficiencies.

iAQount coordinates step-by-step with the FDA, continuously monitoring

the application for additional requirements or compliance.

Clients can rely on iAQount's expertise to expedite the approval process by

facilitating seamless communication with the FDA and ensuring timely
updates.

After Food Registration approval, iAQount provides guidance on post-

compliance requirements.

We orient the client on what's needed post-approval (CPR) to maintain

compliance.
DOCUMENTARY REQUIREMENTS

To be provided and prepared by the Client team under the guidance of the iAQount team:

A. Signed Contract with iAQount

B. Client Information Sheet

C. FDA LTO (License to Operate) as Food Importer/Distributor

D. Product Sample (at least 1 product sample to be submitted to FDA)

E. Copy of Product Label Artworks and Photos of Actual Product at all angles

F. Manufacturer/Supplier Agreement or Distribution Agreement

G. License of the Manufacturer for Food Production, any of the following (HACCP, ISO, FSCC, HALAL, GMP)

H. Certificate of Analysis of the Product

I. Shelf Life Study

J. Product Brochure/Profile
LEAD TIME
FDA Registration - CPR for Prepackaged Food

Procedure Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15

Phase 1

Phase 2

Phase 3

Phase 1 - Document and Product Information Assessment (10 - 15 working days)

This phase begins with a meticulous review of client documents to identify deficiencies and ensure compliance with FDA standards. This critical phase may vary in duration based on how quickly
iAQount receives and processes the necessary documentary requirements. Our aim is to minimize potential gaps, setting the groundwork for a successful FDA registration process by improving the
quality and completeness of submitted documents.

Phase 2 -FDA Application, Evaluation and Approval (20 - 40 working days)

This phase is a pivotal stage where iAQount takes the lead in coordinating with the FDA. We maintain continuous, step-by-step interaction with the FDA, ensuring the client's application is monitored,
updated, and expedited. The duration of this phase may vary if the FDA suddenly requests additional documents or compliance measures that the client's manufacturer cannot immediately provide.
Our expertise helps streamline the approval process and keeps clients well-informed.

Phase 3 - Post-Approval Consultation

After successful Registration approval, iAQount continues to support our clients by guiding them through post-compliance requirements. This phase is vital in ensuring ongoing adherence to FDA
regulations. We provide clients with a clear orientation on the specific post-approval requirements, often referred to as Post-Compliance Requirements (CPR), to maintain their compliance status.
This support aims to keep clients well-prepared and in good standing with the FDA in the long term.
FEES

Raw Material/Low Risk Food Medium Risk Food High Risk Food

Php 8,500 Php 10,000 Php 12,500 - 15,000

Professional Fee Professional Fee Professional Fee
+ + +
FDA Filing Fee FDA Filing Fee FDA Filing Fee

Per one/single product line only.

Additional fees may apply for supplementary assistance, such as the preparation of additional documentary requirements that iAQount
can support the client with to ensure the approval of the Post-Compliance Requirements (CPR). These fees are associated with the
provision of specialized services beyond the scope of the initial agreement to help clients maintain ongoing compliance.
PAYMENT SCHEDULE

Initial Payment Balance Payment

50% of Professional
Fee
50% of Professional
+ Fee
Government Filing
Fee
Upon contract signing and commencement of our The remaining professional fee balance should be
service engagement. settled upon the successful completion of the
service.
iAQount can provide estimated government filing
fees either upon the start of service engagement.