Kappler Pharma Consult berät Firmen aus der Pharmabranche bei der Entwicklung von Arzneimitteln, beantragt und pflegt Zulassungen und organisiert Bioäquivalenzstudien.
Our services:
- Preparation of application files
- e-submissions (eCTD, NEES)
- CP, DCP, MRP including national phases and translations
- National procedures in EU countries and in various non-EU countries
- Variations
- Renewals
- xEVMPD
- Organisation for application slots
- Request for scientific advice
- Submission of all documents module 1-5 to the authorities
- Organisation for payments of fees to the authorities
- Acting as applicant and / or MAH
- Pharmacovigilance during the procedure
- Due diligence projects