Registration

Registration support

We assist you in the development and registration phases of your product with particular focus on scientific regulatory affairs and registration documentation. We have broad experience in the chemistry, manufacturing and quality control (CMC) part of the registration file.

The registration support services that can be undertaken are:

• Regulatory guidance from development to commercialization
• Manufacturing, packaging and release testing of registration batches
• Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines
• Documentation to the CMC part of the registration file
  • Validation master plans, protocols and reports etc.
  • Coordination of the compilation of the CMC part EU
    • CTD  Module 3
    • QOS  Module 2.3
    • IMPD
    • Veterinary  Part 2 & expert report part 1C.3 / Quality
    • CE marking
• Assisting in submissions of INDs, NDAs and ANDAs in the United States
• Reformatting of dossiers
• Assessments & Variations / Amendments
• Updating of old dossiers
• Submission & follow-up of procedures
• Liaison with Regulatory Authorities