Independent CMC and Regulatory Affairs professional, with experience in the development of diverse product modalities, mainly Biologicals and advanced therapies, at all clinical stages. I offer my service as a “flexible” team member in: - CMC Operations, i.e.: - Phase-appropriate CMC strategy and troubleshooting- know WHAT to do, WHEN to do it, and HOW. - CDMO selection and management, - CMC development studies, - Tech transfers, - Risk assessments (process, product, and ad-hoc topics) - Process validation and market readiness, and more... - CMC-Regulatory Affairs, i.e.: - Establish a regulatory strategy or consult on specific Regulatory dilemmas - Preparing your team for regulatory meetings- ask the right questions and prepare the most effective briefing package. - Preparing regulatory submissions (IND, IMPD, NDA , BLA, and technical reports) I have assumed a wide array of functions in drug development projects, and can augment your team in many different ways- so if you need help- let's talk! I also offer professional training in the field, both dedicated to teams and as on-demand content, availble on my website: Beyond CMC- see links below.