Research and Development


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.


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


  • Scientific advices
  • SME applications
  • Due diligences

News in Europe

EMA’s CHMP has started the rolling review of a third COVID-19 vaccine. The vaccine is being developed by Moderna Biotech Spain, S.L.

News in USA

Pfizer and BioNTECH  to submit emergency use authorization request on November 20,2020 to the US FDA for their SARS-Cov-2 mRNA vaccine.