PHILIPPINES FDA Certificate of Product Registration
Certificate of Product Registration
Before a company’s products are allowed entry into the Philippine market, each of these products must undergo separate product registration processes.
Before a company’s products are allowed entry into the Philippine market, each of these products must undergo separate product registration processes. Depending on the classification of the products to be marketed (food, food supplement, drug, cosmetic, household hazardous, pesticides, medical device, diagnostics or veterinary products), there are vastly different registration requirements and respective processing timelines.
Requirements:
- Accomplished and duly notarized application forms No.1 and No.8;
- Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer;
- Copies of valid LTOs for manufacturer/trader/distributor/seller/exporter/importer;
- Unit dose and batch formulation (in metric system);
- Technical specifications on all raw materials;
- Certificate of Analysis on raw materials and finished product from manufacturer;
- Technical specifications of finished product;
- Master manufacturing procedure, poduction equipment, sampling and in-process controls;
- Assay on test procedures and data analysis (if applicable);
- Stability study in accordance with the Philippine national guidelines and ASEAN guidelines;
- Representative sample of packaging and labeling materials for commercial market;
- Copy of ACB approval; and
- Copy of the original Product Registration in the manufacturing country (for foreign manufactured products).
Procedure:
- Submit application and all requirements to Public Assistance Information and Compliance Section of FDA for assessment;
- Proceed to Accounting and Billing Department to have registration fees assesed and paid for;
- Obtain endorsement for Certificate of Registration after evaluation of Product Services Division; and
- Secure signed Certificate of Registration and Product Registration documents from FDA.
BGC and Co. CPAs is a mid-sized progressive auditing firm providing comprehensive set of cost effective solutions to organizations like yours.
Our services include auditing, accounting, bookkeeping, business management, and HR consulting. Further, we provide other business services like VISA processing in Bureau of Immigration (BI), Philippine Retirement Authority (PRA).
We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks effective auditing and assurance services. We understand a value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.
The firm was formed to assist clients on the preparation of compliances relating to tax, financial management, forecasting and accounting software and system installation. Assist clients in tax investigations, internal auditing procedures and provide on financial, taxation, accounting and auditing matters when needed. Processing of business registration, cancellation / termination.
Our Mission
Deliver reliable cost effective professional services in time meeting specific customer requirements.
Our Vision
To become one of the best auditing and accounting firm in the Philippines providing the utmost satisfaction to all the clients. We would like to be known as one of the finest company to partnered with in all the aspects.
Our Team
Our teams of dedicated professionals led by senior qualified accountants are obliged to give you quality services which will enable you to serve your clients better and there by improve your business. We together with our associates enable to give you the best in the industry.
ABOUT OUR SERVICES
Auditing and Assurance
We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks delivering effective auditing & assurance services. We understand value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.
Our expertise in analyzing accounting systems, designing better systems with proper internal controls and management information reporting help our clients to adequately plan their business building strategy and give them the confidence to pace up with the rapidly growing economy.
Accounting and Bookkeeping
Accounting and bookkeeping is a necessity of every organization irrespective of its size. Our professionally qualified and experienced accountants understand and analyze business transactions and ensure compliance with the accounting standards. BGC has well trained staff familiar with many of the accounting system and most especially to the rapid changes in the BIR rules and regulations. Qualitative and timely accounting reports are crucial for the success of any business organization. BGC ensures relevant and reliable financial reports are delivered on regular intervals to assess performance and to facilitate decision making. Outsourcing of accounts department helps you to get professional expertise at lower cost and BGC provides the most efficient and effective bookkeeping solutions.
We assist you with below services:
• Accounts preparation and supervision
• Preparation and presentation of financial reports
• Bookkeeping services
• Payroll processing
• Training of accounting staff
Business Set-up and Termination
We do assist in setting up different types of business organizations through registrations to different government agencies such as:
• Securities and Exchange Commission (SEC);
• Bureau of Internal Revenue (BIR);
• Local Government Unit (LGU);
• Department of Trade and Industry (DTI);
• Social Security System (SSS);
• Philippine Health Insurance (Philhealth);
• Pag ibig;
• Food and Drug Administration (FDA)
We also assist our foreigner clients for the following:
• VISA extension;
• Bureau of Internal Revenue (BIR);
• 9g VISA;
• Special Resident Retiree’s VISA (SRRV)
• Social Security System (SSS);
• Passport Renewal
SERVICES
CONTACT US
ADDRESS
- 7TH FLOOR, PCCI CORPORATE CENTER, L.P. LEVISTE ST., SALCEDO VILLAGE, BRGY. BEL-AIR MAKATI, PHILIPPINES 1209
- Info@bgcco.ph
- lconvento@bgcco.ph
- Working Hours : 8:00 a.m - 5:00 p.m
PROFILE
AUTHORIZED INSTITUTION
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