Drug Development Services

Celerion's Drug Development Services helps pharmaceutical and biotechnology companies demonstrate early evidence of their compounds' clinical efficacy and tolerance in humans.

The knowledge and leadership of highly trained scientists enable clients to design and carry out comprehensive development strategies. Celerion’s integrated service spans the research process for small and large molecule drugs from lead identification through clinical proof-of-concept – and all the way to full clinical development.

Celerion offers expertise in pharmacology, chemogenomics, drug metabolism, pharmacokinetics, analytical chemistry, toxicology and safety pharmacology, bioanalysis, clinical pharmacology, biomarker strategies, early clinical research, regulatory strategy and submissions support, including CMC sections of regulatory documents.

Celerion’s program and project management team provides access to that network to help implement a successful drug program.
Program managers assist clients with implementing and executing comprehensive drug development programs, for both small and large molecule drugs. Celerion’s program managers act as internal advocates to oversee realization of the client’s plan. The collaboration of the client’s project team, with specialists within Celerion and, if required, with recommended third parties such as contract manufacturing organizations, ensures a smooth flow of data and information among the various stakeholders on the team.
Celerion’s experienced global regulatory team helps companies execute sophisticated regulatory processes with strategic and tactical support to meet clients’ objectives and to ensure high quality regulatory documentation and timely communication with regulatory agencies.

The global regulatory team offers direct regulatory support for drug, biological products and medical devices for submissions to North American and European authorities. Services offered include customized regulatory consulting, regulatory submissions preparation, medical and technical writing and global regulatory liaison.