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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.

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:

 

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

 

 

Regulatory Affairs

We competently and reliably equip your pharmaceutical and healthcare products with all regulatory requirements for successful and rapid market access.

 

Quality Management

We support the establishment and optimisation of your QM systems and everything that goes with them in a responsible and experienced manner.

 

Clinical/Medical Affairs

We prepare meaningful clinical and medical reports and documentation for the scientifically substantiated assessment of your products.

 

Vigilance / Surveillance

We take responsibility for the safety monitoring and risk assessment of your products at every stage of their life cycle.

Tentamus laboratories in your vicinity