CMC Regulatory Affairs

Medicinal Chemistry

We are experienced in the coordination, preparation and review of complex multi-national CMC submissions across global markets

We can advise clients with planning, preparation and evaluation of regulatory submissions during development, first registrations and post-marketing stages of product lifecycle

We work with a wide range of product formulations to ensure submissions conform to the current quality standards of regulatory authorities

With more than 14 years Regulatory Affairs experience and demonstrated strong technical and communication skills, we deliver projects in a quality, timely and cost effective manner

We have broad experience of the whole drug discovery process from hit identification, hits to lead and lead optimisation programmes through to selection of preclinical candidates and support for clinical trial

manufacturing

We provide advice on the potential of early screening hits, selection of compounds for hit confirmation and sourcing from commercially available compounds (including close analogues)

We advise on the selection of target compounds and their routes of synthesis during hits to lead and then lead optimisation programmes, liaising closely with the client’s chemists or their chosen chemistry CRO to maximise efficiency of synthesis of test compounds

We will guide the programme using the client’s screening data and the many physical and biological properties of the lead compounds to meet the client’s drug target product profile