Product Registration

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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.

Our distributors rely on our experience and competent staff to complete product registration effectively and efficiently. We stick by our distributors, whether registration takes months or even years, until the product(s) are approved and importation of our products can be initiated.

Being a highly detail oriented process, product registration procedures and requirements vary according to country.

Whether registration be for one of our 400+ pharmaceutical products, our wide and growing range of supplements, medical devices from one of our five brand divisions, or our veterinary range, we will see the process through to the end.

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.

Registration Process

Manufacturing
Agreement

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

Factory
Inspections

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

Dossier
Preparation

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

Packaging
Design

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

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

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

Registration
Approval

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

Become a Distributor

Step 1

Registration Process

Manufacturing Agreement

The terms, conditions, and specifications of the AdvaCare-Distributor relationship are clearly stated. Prior to finalizing an agreement, AdvaCare must approve the client.

However, we realize that small-bulk distributors are equally entitled to the privileges of our large-bulk distributors. To this end, we work closely with our customers to help them grow their markets. AdvaCare also believes in conducting business in a transparent manner as reflected in our relationships with our customers.

Step 2

Registration Process

Factory Inspections

Some countries require a facility inspection by their MOH officials, unless previously inspected, in order to complete product registration.

Factory inspections are required by many countries to ensure that facilities producing the medicines and healthcare products consumed by their citizens are safe and effective. Other countries only require specific documentation proving safety and quality standards. AdvaCare supports such inspections and has vast experience in working with inspectors to make sure requirements are met.

Step 3

Registration Process

Dossier Preparation

Advacare begins preparing all necessary documents according to the importing country’s requirements. Dossiers and other documents needed for registration are vital to registering healthcare products in any country.

AdvaCare’s registration department has vast experience in successfully registering hundreds of our products worldwide. Health ministries around the world know that when AdvaCare products are being registered, the process will be efficient and accurate.

Step 4

Registration Process

Packaging Design

Packaging is designed according to both market demands and distributor requirements. Excellent packaging is one of the most important aspects in marketing our products.

AdvaCare brands are packaged with the best materials and according to the highest standards. Our customers can also package our products according to their specifications and requirements.

Step 5

Registration Process

Sample Production

Samples are required by most countries for testing in order to complete product registration. Samples are produced according to the standards (USP, BP, etc.) required for product registration.

We pretest samples to ensure their purity and uniformity, the two most important criteria for sample testing. AdvaCare has gained a reputation with health ministries around the globe, often foregoing standard sample submission requirements.

Step 6

Registration Process

Registration Submission

After all documents have been prepared and samples produced, the healthcare product(s) are submitted for approval.

It is vital to the success of not only the product(s) being registered, but also all future products to be registered by AdvaCare, that accuracy is absolute. One small error can result in the failure of product registration, costing AdvaCare and our customers time and money. For this reason, we meticulously verify the accuracy of all documents and samples submitted.

Step 7

Registration Process

Registration Approval

Successful product registration is necessary to import our products.

AdvaCare has successfully completed the registration process with numerous health ministries, agencies, and administrations around the world. Our products can be found on 4 continents for one important reason: we are excellent at what we do. AdvaCare has a global reputation for quality and value…from Asia to Africa, customers and consumers rely on our ability to successfully register our products around the world.

FACILITY INSPECTION

Inspection and licensing of pharmaceutical manufacturing facilities on the basis of compliance with GMP are a vital element of drug control. AdvaCare supports WHO initiatives aimed at improving inspection techniques and increasing the frequency of inspections for the common good of society.

Besides the internal and third-party inspections we frequently conduct for quality assurance purposes, we routinely host government inspectors from abroad to gain their approval when preparing to enter new markets.

Government inspectors represent the enforcement arm of a national drug regulatory authority. Its function is to ensure adherence by manufacturers to all licensing provisions and specifically to GMP. The objectives are to provide authorization for the importation of the manufacturer’s products into the country of the inspectors.

The first objective involves a sequential examination of production and control activities on the basis of GMP guidelines issued by the WHO or of nationally determined requirements.

The second requires verification that production and quality control procedures employed in the manufacture of specific products are performed correctly and that they accord with data supplied in the relevant licensing applications. Inspection is also dependant on other factors such as the national legislation and regulations of the inspector’s country and/or resources available.

While the inspection criteria and procedures vary from country to country, their results do not. AdvaCare products have successfully been approved by health ministries and agencies from Australia to Africa, the Middle East to Asia.

We realize that the future of our company depends on our continued product improvement and market expansion. Facility inspections are a top priority for us and their results reflect our policy of constant improvement and meticulous attention to detail.

Do you require factory inspection?
Contact Registration Dept.

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.

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.

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

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.

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.

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.

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.

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.

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.

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Already an AdvaCare Distributor?

Contact Us:

Step 1

Registration Process

Manufacturing Agreement

Step 2

Registration Process

Factory Inspections

Step 3

Registration Process

Dossier Preparation

Step 4

Registration Process

Packaging Design

Step 5

Registration Process

Sample Production

Step 6

Registration Process

Registration Submission

Step 7

Registration Process

Registration Approval

Become a Distributor:

Contact Registration Department:

GMP (Good Manufacturing Practice)

CE (European Conformity)

ISO (International Standardization)

COA (Certificate of Analysis)

COPP (Cert. of Pharmaceutical Product)

FSC (Free Sale Certificate)

Contact Us: