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Partner with an Expert in CMC Pharmaceutical Consulting
At Pyrenees Pharmaceutical CMC Consulting, LLC, we help pharmaceutical innovators at every stage of product development — from early formulation design to complex regulatory submissions.
We specialize in supporting small-to-midsize pharmaceutical companies and research organizations, guiding them through every phase of Chemistry, Manufacturing, and Controls (CMC) development with clarity and precision.
Our services include analytical method validation, formulation optimization, regulatory technical writing, and CRO/CDMO project management. Each service is designed to ensure your product advances efficiently, safely, and in full regulatory compliance.
Every project is unique. That’s why we take the time to understand your objectives, timelines, and requirements before creating tailored solutions. With over 25 years of combined academic and industry experience, our team delivers science-driven results that align with your business goals and regulatory expectations.
How to Reach Us:
Serving clients across the United States
+1 201.906.6155
jason.lepree@pyreneespharma
consulting.onmicrosoft.com
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Your Strategic Partner for CMC Pharmaceutical Development.
Choosing the right partner for your CMC pharmaceutical consulting needs can make the difference between project delays and a successful market launch.
At Pyrenees Pharmaceutical CMC Consulting, we combine technical excellence, regulatory insight, and a client-focused approach to help you overcome development challenges with confidence.
We don’t just deliver services — we deliver measurable results that are compliant, efficient, and strategically aligned with your objectives. Whether you need preformulation studies, analytical method development, formulation optimization, or regulatory submission support, our team brings the proven experience to help your projects succeed.
Our commitment goes beyond completing tasks — we act as an extension of your team, offering the insight, leadership, and hands-on execution needed to accelerate timelines and reduce risk.
With deep expertise in IND, NDA, ANDA, and NADA submissions, we understand how to navigate the global regulatory landscape and bring safe, high-quality therapies to market efficiently.
If you’re ready to move your pharmaceutical project forward with a trusted, science-driven consulting partner, let’s connect today.