Regulatory Affairs CMC services

Ask an expert for advice

Internationally qualified CMC expert with primarily small molecule experience but with supplementary experience in biologics and for ATMPs.


With comprehensive experience in drug development aiming for a specific target product profile, I design development plans tailored to every client’s specific needs.


I provide cost effective solutions based on a deep understanding of prior clients

As the regulatory affairs expert i am dedicated to work in close collaboration with you as client to ensure the confidential disclosure agreement (CDA) is signed prior to proprietary knowlegde being shared with service providers, ensure the

request for proposal contains all required information for a clinical or commercial application through to manufacturing for commercialization as well as global registration support and maintenance.


Independent expert with more than 20 years experience in the pharmaceutical industry 

I worked both on contract giver side and contract taker side and throughly know both sides



Regulatory Affairs CMC advice for CDA and proposals 

Knowing the current and upcoming changes to the legislation and guidelines is paramount to drug developement. 20 years of experience in Regulatory Affairs have shown how being on the forefront ensured that delays can be avoided with forward planning. 

Technical CMC writing and review (gap analysis)

Knowing the little details required before the health authorities asks for them gives trust (and less scrutiny). Being able to write with just sufficient detail and not investing money in data being generated to early will ensure you as client can prioritise. 

Scientific advice and regulatory Affairs interpretation

knowing how to set up the meeting, write the minutes for those authorities required this and prepare the briefing book is of most importance.