Services
Comprehensive CMC Pharmaceutical Consulting Services
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Consulting Services
At Pyrenees Pharmaceutical CMC Consulting, LLC, we provide a full range of Chemistry, Manufacturing, and Control (CMC) consulting services designed to help pharmaceutical companies meet scientific, operational, and regulatory requirements efficiently. Our expertise supports every phase of drug development, from early-stage preformulation to commercial manufacturing, with solutions tailored to small-to-midsize companies and research institutions.
Learn more about our CMC development process
Analytical Method Development & Validation
We design and validate fit-for-purpose analytical methods to accurately measure actives, impurities, residual solvents, and degradation products. Our team also develops dissolution assays with in vitro–in vivo correlations, ensuring methods are scientifically sound and compliant with global regulatory standards.
Preformulation Studies
Our preformulation capabilities include design and interpretation of solubility profiling, forced degradation testing, physical characterization, and excipient compatibility studies. We perform solid-state analysis to identify polymorphs and critical material attributes that can impact formulation performance and stability.
Formulation Development
From concept to commercialization, we design and optimize pharmaceutical formulations using Design of Experiments (DoE) for process efficiency. Our experience covers lipid-based dosage forms, solid dispersions, long-acting injectables, ophthalmic solutions, and nasal spray formulations. These solutions are engineered to improve bioavailability, patient adherence, and product stability.
Due Diligence & Technical Writing
We provide expert technical documentation for regulatory submissions, including Module 3 of the Common Technical Document (CTD) for IND, NDA, ANDA, and NADA filings. Our services also cover data review, regulatory support documents, and clear, compliant technical writing to meet FDA, EMA, and ICH guidelines.
Intellectual Property & Legal Support
We assist with patent strategy development and freedom-to-operate (FTO) analyses to protect intellectual property and ensure competitive positioning in the marketplace.
Technical Project and CRO/CDMO Management
We lead multidisciplinary teams through complex CMC projects, managing timelines, budgets, and risk mitigation using industry-standard project management methodologies. We help our clients identify the right CRO/CDMO for their projects and provide direct technical oversight of the work packages.
KEY ACHIEVEMENTS
Proven CMC Success and Industry Leadership
Our track record demonstrates measurable results across multiple dosage forms, therapeutic areas, and regulatory environments. Led by Dr. Jason M. LePree, Pyrenees Pharmaceutical CMC Consulting has delivered solutions that advance products from the laboratory to the clinic and marketplace with efficiency and compliance.
Highlights include:
- Authored analytical and formulation sections for multiple Investigational New Drug (IND) applications, 2 New Drug Applications (NDAs), 2 Abbreviated New Drug Applications (ANDAs), and 1 New Animal Drug Application (NADA).
- Developed analytical methods and formulations for New Chemical Entities (NCEs), 505(b)(2) products, and generic formulations across solid oral, liquid oral, injectable, and nasal spray formats.
- Established and directed the Gattefossé North American Technical Center of Excellence Pharmaceutical Application Laboratory, advancing lipid-based formulation R&D and conducting technical seminars for global clients.
- Recruited, trained, and mentored cross-functional laboratory teams to deliver high-quality analytical and formulation services that meet strict regulatory standards.
- Serves as Adjunct Professor at the University of Wisconsin–Madison and Saint Thomas Aquinas College, teaching advanced courses in Drug Development and Quantitative Analytical Chemistry.
Closing Statement:
These achievements reflect a consistent commitment to excellence, innovation, and client success. Every project benefits from our unique combination of scientific rigor, regulatory insight, and strategic execution, ensuring a smooth path from development to market.
Our CMC services align with FDA guidelines for pharmaceutical development.