Research and Development
Services
The constant in the pharmaceutical industry is change
The development of biotechnology-derived products is complex and basically determined by numerous Regulations, Directives and Guidelines but more often demand unique solutions.
While you are focussing on your technology, I will bring considered international and local understanding of Regulatory requirements for a goal-oriented development.
While you are focussing on your technology, I will bring considered international and local understanding of Regulatory requirements for a goal-oriented development.
Services
Clinical Studies
Preclinical Studies
Chemistry, Manufacturing and Control (CMC)
Others
- Strategic planning
- Preparation of clinical trial applications (CTAs)
- Submissions
- Communication with health authorities on behalf of the sponsor
- Coordination of the CTA procedure
- Internal and on-site audits
Preclinical Studies
- Strategic planning
- Preparation of preclinical study protocols and reports
- Integration of preclinical study information in clinical trial relevant documents
- Internal and on-site audits
Chemistry, Manufacturing and Control (CMC)
- Specifications
- Preparation of CMC-releated documents for CTAs
Others
- Scientific advices
- SME applications
- Due diligences