Generic Dossiers & Licensing

Regulatory Services

Scientific Regulatory Affairs

NextPharma supports our customers in the development and registration phases of their products, with particular expertise in scientific regulatory affairs and registration documentation.

Acting on our customers' behalf NextPharma regularly delivers the following services:

    • Co-ordination of the compilation of the CMC section
      • CTD  Module 3
      • QOS  Module 2.3
      • IMPD
    • Reformatting and updating of Dossiers
    • Variations preparation
    • Submission and follow-up of procedures

We also support the submission of INDs, NDAs and ANDAs in the USA.

In addition, NextPharma has acquired expertise in veterinary dossiers (Part 2 and expert report part 1C.3 / Quality) and CE mark products.

Glossary

CMC: Chemistry, Manufacturing and Controls
CTD: Common Technical Document
QOS: Quality Overall Summary
IMPD: Investigational Medicinal Product Development
IND: Investigational New Drug Application
NDA: New Drug Application
ANDA: Abbreviated New Drug Application