We assist you in the development and registration phases of your product with particular focus in scientific regulatory affairs and registration documentation. We have a 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