Kappler Pharma Consult GmbH

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