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.

Clinical Studies

• 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