Navigating CMC Pharmaceutical Development Challenges, Delivering Excellence
At Pyrenees Pharmaceutical CMC Consulting, we help pharmaceutical innovators navigate the complex landscape of Chemistry, Manufacturing, and Controls (CMC) Development.
Our focus is simple: to turn scientific innovation into safe, effective, and compliant therapies.
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About Us
Moreover, our mission is to help small-to-midsize pharmaceutical companies and government agencies — including organizations such as the NIH — transform promising concepts into market-ready solutions with precision, efficiency, and full regulatory alignment. As a result, our clients can move confidently from research to commercialization without unnecessary delays.
Our CMC pharmaceutical consulting services cover the full development cycle, including analytical method development and validation, formulation design and optimization, and regulatory technical writing.
In addition, we provide strategic project management tailored to your specific timelines and scientific goals.
Every step we take is designed to ensure your success.
Guiding Projects from Discovery to Launch
With over 25 years of combined academic and industry experience, our team integrates deep technical expertise with practical leadership.
Furthermore, we ensure that every project — from early discovery to commercial launch — advances seamlessly while maintaining scientific integrity and regulatory compliance.
Ultimately, our goal is to help clients achieve long-term success with confidence and clarity.
Our Services at a Glance
At Pyrenees Pharmaceutical CMC Consulting, we provide science-driven guidance throughout the entire CMC lifecycle. From analytical method development to regulatory submissions, we help small-to-midsize companies and government agencies move their projects from early discovery to market approval — with confidence and precision.
Analytical Method Development & Validation
Reliable, fit-for-purpose methods that support your drug development process.
Preformulation Studies
Early insights into solubility, polymorphic form, salt selection, stability, and excipient compatibility.
Formulation Development
Optimized dosage form design for solid, liquid oral, injectable, ophthalmic, and nasal drug products.
Regulatory Technical Writing
Clear, compliant Module 3 CTD authoring for IND, NDA, ANDA, and NADA submissions.
IP & Legal Support
Patent strategy and freedom-to-operate (FTO) analyses to protect your formulations.
Project Management
End-to-end leadership that keeps your timelines and budgets on track.
Tailored CMC Solutions for Every Stage of Development
Every pharmaceutical development journey is different. That’s why our approach is never one-size-fits-all. Instead, we design fit-for-purpose analytical methods, conduct comprehensive preformulation studies, and develop advanced formulation strategies that improve bioavailability and stability.
In addition, for companies preparing IND, NDA, ANDA, or NADA submissions, we bring deep expertise in writing Module 3 CTD sections and ensuring complete data integrity. Moreover, we work hand in hand with your teams to anticipate challenges, streamline workflows, and meet every regulatory milestone efficiently.
When you partner with Pyrenees Consulting, you gain more than a consultant — you gain a strategic ally. Together, we help you deliver safe, effective, and compliant therapies to the patients who need them most.
What Our Clients Say
Finally, discover how our partners describe their experience working with Pyrenees Pharmaceutical CMC Consulting. Their words highlight the trust, expertise, and value we bring to every collaboration.