PREPARATION/SUBMISSION OF MARKETING AUTHORIZATION APPLICATIONS
- National registration.
- MRP/DCP/CP registration.
- Human medicinal products (MPs, DCP, MRP, NP).
- Veterinary medicinal products (VMPs, DCP, MRP, NP).
- Medical devices.
Regulatory affairs
SPECIAL MEDICINES AREAS
- Innovative and generic medicinal products (including biotech),
- herbal medicinal products (natural medicines),
- strong vitamin and mineral products,
- medicinal gasses,
- radiopharmaceuticals,
- food supplements,
- cosmetics,
- biocides,
- vaccines,
- homeopathic medicinal products,
- blood products and plasma-derived medicinal products.
EXPERT REPORTS – PRE-AUTHORIZATION – POST-APPROVAL AND SUBMISSION SUPPORT
- various applications, renewals, and notifications,
- update and upgrade of documentation,
- SPC, PIL, labelling in accordance with national legislation,
- marketing materials review, harmonization with approved medicinal products documents,
- communication with authorities (new requirements/answers to deficiency/ clarifications/permissions),
- packaging materials (mock-ups/artworks) and proofreading.