Is your team able to jump over the highest bars?
Our expert services include Global and Strategic Regulatory Affairs, and International Regulatory Affairs, FDA Regulatory Affairs, EMEA Regulatory Affairs, UK Regulatory Affairs, etc.
Chemistry Manufacturing Controls (CMC) is an area that many companies struggle to find expert support for. Our services include developing CMC strategies for all types of molecules, including large and small molecules. We help companies identify one stop shops for manufacturing of Drug Substance and Drug Product.
Clinical Research Services include:
Development of clinical strategy, writing the clinical protocol, writing the Investigator’s Brochure, development of the informed consent document, and much more.
Our informed consent services include the development of the informed consent document, and the process. We train the investigative site staff on Good Clinical Practice, and the process of ensuring all study participants are correctly informed consented.
Pharmacovigilance services include training of physician monitors, and study personnel. We supplement the Pharmacovigilance staff for Contract Research organizations. Pharma and biotech companies cannot afford to deprioritize pharmacovigilance. We help you to get it right. Our pharmacovigilance services include interpretation of toxicological data in relation to the clinical picture that may arise.
Additional Services:
Due diligence for Venture Capital and Investors
Target Product Profile development
Licensing support
Electronic Common Technical Dossier support services
Document management services