Proficiency Profile

full scope of experience regarding planning, preparation and submission of national German applications for medicinal products
broad contact to relevant decision making responsibles within the German health authorities
full scope of experience with regard to planning, preparation and submission of applications for medicinal products to authorities within the European Union (MRP / DCP)
certification / registration of in-vitro diagnostica

constant up-dates on regulatory requirements
provision of regulatory advice prior to acquisition of new products (due diligence activities)
coordination / advice regarding product sales
representation of companies at authorities and third parties regarding regulatory matters
recruitment / evaluation of contract partners (such as manufacturers, quality control labs, analytical development and test labs, contract research organisations)
integration work in the course of company mergers

assessment of compliance
harmonisation of regulatory and pharmaceutical requirements for medicinal products
conception of chemical-pharmaceutical tests for medicinal products
initiation of specific quality tests in cooperation with external laboratories
up-date of quality asssurance handbooks, including for TÜV-certified companies
Handling of deficiencies in the course of certificate renewals and implementation of updates into the QA handbook

development / build-up and (re-)organisation of department structures
recruitment of qualified staff
structure and implementation of new organisation systems (such as documentation, archiving, reporting system)
application of project management tools