Pharmaceutical quality

Quality counts

Proof of pharmaceutical quality is a central element in medicinal product documentation. From the outset you can lay the foundations for the acceptance of your pharmaceutical quality by the regulatory authorities – and hence fulfil the conditions for successful marketing authorisation. We offer competent consultancy support in connection with all questions that occur during the lifecycle of your medicinal products.

Our services at a glance:

• Consultancy services during the development process
• Preparation of quality dossiers
• Technical, content-related support for your marketing authorisation procedures
• Preparation and implementation of quality-related scientific advice consultations with the regulatory authorities
• Answers to questions raised by the regulatory authorities (preparation of response documents)
• Assistance in fulfilling obligations (conditional authorisations)
• Maintenance of marketing authorisations