Product Registration

The main responsibility of all government drug regulatory agencies across the globe is to ensure that all products made available to its citizens conform to acceptable standards of quality, safety, and efficacy.

AdvaCare supports these regulations and assists various governments with the process, on behalf of our distributors, in order to meet the health demands of their population.

AdvaCare has registered hundreds of our pharmaceuticals and healthcare products worldwide. Our highly experienced registration department deals with all matters relating to the registration of our products.

Registration Process

Manufacturing Agreement

Manufacturing
Agreement

The terms, conditions, and specifications of the AdvaCare-Distributor relationship are clearly stated.

Factory Inspections

Factory
Inspections

AdvaCare supports factory inspections and has vast experience in working with inspectors to make sure requirements are met.

Dossier Preparation

Dossier
Preparation

Advacare begins to prepare all necessary documents according to the importing country’s requirements.

Packaging Design

Packaging
Design

Excellent packaging is one of the most important aspects in marketing our products.

Sample Production

Sample
Production

Samples are produced according to the standards (USP, BP, etc.) required for product registration. We pretest samples to ensure their purity and uniformity.

Registration Submission

Registration
Submission

We meticulously verify the accuracy of all documents and samples submitted.

Registration Approval

Registration
Approval

AdvaCare has successfully completed the registration process with numerous health ministries, agencies, and administrations around the world.

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FACILITY INSPECTION

DOCUMENTATION

Proper documentation is essential in almost every aspect of the pharmaceutical industry. Whether for product registration, factory inspection, or internal quality control, AdvaCare employs the latest technologies to streamline and process information.

All facilities possess up-to-date Good Manufacturing Practice (GMP), CE, TUV, and/or ISO certificates that reflect high quality standards and WHO rules and regulations.

Essential product registration documents, such as the Certificate of Pharmaceutical Product (COPP), Free Sales Certificate (FSC), Certificate of Origin (COO), and Marketing Authorizations are among the many documents our registration department frequently submit for registration purposes.

Likewise, technical files are repeatedly checked for consistency and accuracy for both internal quality control purposes and in preparation of inspections.

AdvaCare is highly specialized in the export process and has vast experience with documentation for product registration. Our customers realize the value in registering our products – the value of quality, time, and reliability.

GMP (Good Manufacturing Practice)

The Good Manufacturing Practices are regulated to ensure that recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling meet or exceed internationally recognized standards and follow WHO protocol.

GMP

CE (European Conformity)

CE Certification and markings for medical supplies and medical diagnostic tests reflects that such products meet EU safety and health requirements. This certification also confirms that a proper quality assurance system is employed and enforced.

CE

ISO (International Standardization)

The ISO family of standards, enforced by the International Organization for Standardization and national standards bodies, ensures that products and facilities conform to acceptable quality management systems.

ISO

COA (Certificate of Analysis)

The Certificate of Analysis is the document which lists the formula for the ingredients, the amount of each raw material and ingredient, and the results of tests proving the purity of a pharmaceutical product.

COA

COPP (Cert. of Pharmaceutical Product)

The Certificate of Pharmaceutical Product states the marketing status of the product in the country of origin. It also states that the facility and product complies with GMP and regular inspections. This document is also called a WHO Certificate.

COPP

FSC (Free Sale Certificate)

The Free Sale Certificate reflects that the quality of a product is suitable for being placed on the market, but does not guarantee that the product is necessarily marketed in the country of origin.

FSC