We offer consulting for pharmaceutical entrepreneurs – whether start-up or global player – on all questions pertaining to Market Access.
For us the legal framework for clinical studies is just as familiar as the requirements for national and European authorization procedures. Major decisions during the lifecycle of a medicinal product are based on drug safety issues.
We provide consultation regarding the implementation of provisions for pharmacovigilance, issues of outsourcing and the contracts required for this purpose.
In addition to the importance of research and development, authorization and pharmacovigilance we are familiar with the significance of GMP-compliant production and GDP-compliant distribution as well as their obstacles with increasing industrialization.
We stand by our clients during regulatory licensing and approval procedures defend their interests in court and represent them in preliminary proceedings due to breaches of pharmaceutical law.
Areas of focus
- Clinical trials and non-interventional studies
- Approval procedures for generics
- Traditional and homeopathic registration procedures
- Parallel-imports and re-imports
- Labelling, leaflets, specialized information (SmPC)
- Sunset clause
- Risk procedures (Referrals and graduated plan procedures)
- License for production, import or wholesale
- Preliminary proceedings regarding pharmaceutical law
- Client-specific in-house training