Tailored CMC Regulatory Strategies for Small Businesses
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RegulatoryCatalyst specializes in guiding pharmaceutical and biotech companies, especially startups, through complex regulatory pathways. Our strategic Chemistry, Manufacturing, and Controls (CMC) solutions are designed to streamline approvals and reduce costs, giving you a competitive edge.
REGULATORY CMC EXECUTIVE AND STRATEGIC CONSULTANT
I empower Small-Medium Pharma/Biotech Companies to gain competitive advantage using RA CMC optimized approaches.
Former Big Pharma Associate Director with 18 years building regulatory CMC operations for emerging pharmaceutical and biotech companies. I step in as interim executive or strategic director to establish world-class regulatory departments that accelerate market access across EU (EMA), US (FDA), Canada, China, Japan, and 15+ global markets.
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100+ successful global submissions with 20% faster approval timelines than agencies estimates. For companies where delayed market access costs thousands daily, I consistently deliver accelerated pathways to commercial success.
IDEAL FOR:
Small-medium pharmaceutical/biotech companies needing interim regulatory CMC leadership, emerging biotechs planning first global submissions, and growing companies establishing scalable regulatory operations.
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Ready to discuss your regulatory CMC strategy? Let’s connect!
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TESTIMONIALS
Client Reviews
Peter L.
Dear Jeremy,
It's been a pleasure working with you. PPL is very satisfied with the work conducted and the service provided during
the transfer of the RA responsibility to PPL
Clara F.
Mr. Jakob performs his tasks with especial commitment and takes obvious pleasure in his
work. He is reliable, responsible and particularly trustworthy at all times.
His fast way of working enables him to produce very good results.
Jakob B.
Jeremy is a very knowledgeable regulatory affairs professional. I appreciated his global technical CMC/Quality writing experience for small molecules and biologics DS and DP manufacturing documentation.
Our clients appreciate the expertise and dedication of RegulatoryCatalyst. Discover what they have to say about our transformative regulatory solutions.