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.

Services

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

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.
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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.
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