The submission of a document according to which the quality of a drug will be controlled is required for the registration of a drug product or a drug substance.

This document is a regulatory document (normative document) for products and substances manufactured abroad and in Russia.

The documents are similar both in purposes and in contents.

The normative document consists of:

- specification, where quality parameters of a drug, evaluation of every parameter and limits are determined;

-  description of composition (active ingredient and excipients) and apperance of the product;

-  description of identification, mean weight, рН, desintegration, dissolution, content uniformity methods;

- microbiological quality, assay, and impurities methods;

- description of container closure system, labeling, storage conditions, and shelf-life.

ConsultPharma specialists are experienced not only in preparation of regulatory documents, but also in their development.

In case you do not have methods and their validation, we will prepare a regulatory document, conduct the validation. Of course, it will take more time, but we do this kind of work.