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  Services  »  Regulatory Support

Regulatory Support

Pharmacelsus provides the strategic development planning and execution necessary to advance promising compounds and concepts into clinical testing.

 

Strategy development for entering clinical trials

Taking a drug candidate from early preclinical testing to first-in-man trials requires a solid knowledge of the regulatory framework and a comprehensive understanding of the complex drug development process.

Pharmacelsus supports customers with a better understanding of the developmental needs in the preclinical drug development stage.

  • In the initial step, a technology evaluation helps customers to identify compounds with the greatest potential to produce safe and effective drugs.
  • At the next level, Pharmacelsus performs a more detailed evaluation of the novelty of the customer’s concepts and approaches, identifies potential indications, and looks for patent status, market and medical needs.
  • At the final level, a comprehensive drug development plan up to clinical phase I/II trials can be provided in close collaboration with the sponsor.

 

Scientific Documentation - Regulatory Medical Writing

GLP FDA EMA OECD

Pharmacelsus assists its customers with creating the documentation for the regulatory agencies in the approval process for drugs.

Pharmacelsus' consulting service is closely correlated with the in vitro and in vivo preclinical testing services. A team of professionals and project managers is supported by a core team of experts with expertise in selected preclinical areas such as toxicology, target-based bioassays, pharmacokinetics and bioanalytics.

 

Publications

In order to provide critical support to the customers, Pharmacelsus has assembled a collection of the most relevant information into a short review covering in vitro drug screening, pharmaceutical technology, pharmacological drug profiling, in vivo pharmacology and toxicology, and regulatory issues. A copy of the report can be downloaded after registering.