Strategies and Services for Medicinal Products
Attractive indications and meaningful claims make drugs the most valuable assets in the portfolio. In addition, attractive products with a strong market position can form the basis for portfolio expansions – even beyond the boundaries of marketability and indication areas.
We analyse the potential of your medicinal products in terms of market opportunities and sustainability and advise on all strategic considerations relating to drug approval and your portfolio.
Do you require help or further information?
Contact us! We are happy to advise you:
Product care from an experienced hand
We would be pleased to accompany your medicinal products from the product idea through the approval process to quality and lifecycle management including all analytical tasks. Experienced and practice-oriented, in an advisory and executive capacity.
The spectrum of our services is always oriented towards the specific concerns and requirements of our customers.
On behalf we take responsibility:
- Regulatory Affairs Services / Registrations
- Development and maintenance of QM systems (GMP, GDP)
- Pharmacovigilance
- Clinical & medical assessment
- Drug / batch release as a service
- Audits (incl. API) & inspections
- Quality control & stability testing
- Release test and EU retest
We take over responsible roles:
- Information Officer (acc. to § 74a AMG)
- Graduated Plan Officer (acc. to § 63a AMG / EU-QPPV)
- Responsible Person for Wholesale Trading (acc. to § 52a AMG)
