Dossier for registration

Notary documents

The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Read more…

Common Technical Document

Notary documents

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. Read more…

Common documentation for registration of pharmaceutical products

Notary documents

Every country has its own system and requirements in order to register a pharmaceutical or veterinary product. Although the required documents and procedures vary quite a bit most have many similar requirements for documents in order to ensure that the product being registered meet their standards for efficacy, safety and quality. To ensure quality standards are met, the appropriate regulatory authority in the intended drug market may request documents about the drug in question such as the COPP, FSC, Complete Registration certificates from other countries, Product Registration Dossier and others. Read more…

Essential medicines and products

WHO logo

Medicines quality assurance

Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections. Read more…

Pharmaceutical products

Pharmaceutical molecule

Pharmaceutical products – more commonly known as medicines or drugs – are a fundamental component of both modern and traditional medicine. It is essential that such products are safe, effective, and of good quality, and are prescribed and used rationally. Read more…