7 Easy Steps for Pharmaceutical Registration

Step 1 - Manufacturing Agreement

The terms, conditions, and specifications of the Eternal Mark-Distributor relationship are clearly stated. Prior to finalizing an agreement, Eternal Mark 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. Eternal Mark also believes in conducting business in a transparent manner as reflected in our relationships with our customers.

Step 2 - 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. Eternal Mark supports such inspections and has vast experience in working with inspectors to make sure requirements are met.

Step 3 - Dossier Preparation

Eternal Mark 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.

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

Step 4 - 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.

Eternal Mark 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 - 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. Eternal Mark has gained a reputation with health ministries around the globe, often foregoing standard sample submission requirements.

Step 6 - 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 Eternal Mark , that accuracy is absolute. One small error can result in the failure of product registration, costing Eternal Mark and our customers time and money. For this reason, we meticulously verify the accuracy of all documents and samples submitted.

Step 7 - Registration Approval

Successful product registration is necessary to import our products.

Eternal Mark 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. Eternal Mark 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.

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Proper documentation is essential in almost every aspect of the pharmaceutical industry. Whether for product registration, factory inspection, or internal quality control, Eternal Mark 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.

Eternal Mark 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.

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Eternal Mark Pvt. Ltd.
Room 301, Kam On Building,
176 Queen's Road Central, Central, Hongkong.



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