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 Pharmacovigilance Risk Assessment Committee (PRAC) confirmed a possible link between the rare cases of thrombosis and Janssen's COVID-19 vaccine.
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News in Europe

Transmission is still widespread in the EU/EEA. It is possible that further increases in admissions to hospital, ICU and mortality will follow in the coming weeks in those countries that are currently observing increasing case notification rates. Hence, it is still important to maintain public health and physical distancing measures.
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News in USA

FDA and CDC recommends to pause the administration of Janssen's COVID-19 vaccine until the cases of thrombosis were adequately investigated.
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