Transforming Regulatory Affairs from Roadblock to Pathway for Success

OUR MISSION

RegulatoryCatalyst specializes in helping emerging Pharma/Biotech Leaders facing a technical regulatory urgency to secure their submission packages, by providing blueprints and pathways, alleviating major risks threatening their approval timelines.

Our strategic Chemistry, Manufacturing, and Controls (CMC) solutions are designed to streamline approvals and reduce costs, giving you a competitive edge.

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WE PROVIDE REGULATORY CMC EXECUTIVE AND STRATEGIC CONSULTATION

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You are a leader in biotech or pharma, you strive for scientific and regulatory excellence, and you want to secure and accelerate your clinical development without burning capital — while staying fully in control of your timeline and quality.
Read this carefully.
I have spent more than 18 years in the global pharmaceutical industry, working at the intersection of technical and regulatory strategy within high-performance organizations such as Novartis, Lonza, and Sanofi.

From RA CMC Director to Founder of J2 RA CMC Services Ltd, I have supported complex programs with the EMA and FDA, built regulatory submission strategies from first-in-human through post-approval, and conceptualized end-to-end regulatory processes.

After witnessing firsthand how much time and money biotech companies lose due to a lack of integrated regulatory strategy, I created Reg CORE™ — a structured and modern framework that gives biotech leaders a clear, quantified, and validated regulatory roadmap, without relying on large, expensive consultancies or isolated freelancers.

I have helped startups and small pharma/biotech entities reduce regulatory uncertainty on both content and timelines, avoid major objections (including FDA Complete Response Letters), and secure their investor milestones.
Today, I help biotech founders and development leaders build robust regulatory plans, avoid CMC/clinical strategy missteps, and gain several months on their development timelines — a decisive competitive advantage at this stage.
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If today you face any of these challenges:
❌ Your team is under pressure to deliver a CMC dossier without regulatory certainty;
❌ Your external consultants work in silos and don’t give you a clear view of risks;
❌ You want to anticipate agency questions but don’t know where to start;
❌ You lack the time and resources to absorb the cost of re-work or re-submission;
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📢 Then it’s time to adopt a structured approach:
✅ Get a validated regulatory roadmap (EMA + FDA) in 45 days — and run your project with full visibility.
✅ Reduce regulatory risk before submission, with a compliance analysis and a transparent readiness score.
✅ Free your team to focus on clinical and data priorities while the regulatory framework is secured.
✅ Save several months on your approval timeline and increase the perceived value of your development program with investors.

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