What is CMC in Pharma? It's Who We Are

What is CMC & Why It Matters

CMC (Chemistry, Manufacturing, and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. CMC is a critical component of all pharmaceutical products that cannot be overlooked. In pharmaceuticals, CMC makes sure that every batch of medicine is made exactly the same way, whether it’s used in a clinical trial or sold commercially. It ensures that the drug remains stable over time. is manufactured with strict quality controls and passes all appropriate tests, and meets all safety requirements set by regulatory agencies like the FDA. Without meeting all CMC requirements, a drug couldn’t be approved or trusted for use to ensure safety and efficacy.

Appropriate CMC rigor applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing. The manufacture and testing of all pharmaceutical products must comply with FDA, ICH, and GMP guidance and regulations. Without developing the appropriate CMC package, the product would be deemed unsafe and FDA approval would not be achieved.

Our End-to-End Approach

Who We Are

There’s a reason it’s in our name. At CMC Pharma, we embed CMC into every stage of development. Our scientists and regulatory experts work together so every data point is not only scientifically sound but also submission-ready. This integration reduces risk, avoids delays, and ensures alignment with FDA, ICH, and cGMP standards.

Without strong CMC, promising drug candidates face stalled approvals, regulatory deficiencies, and market setbacks. With CMC Pharma, your CMC strategy is built in from day one to accelerate timelines and de-risk your path to market.

CMC Pharma is a fully integrated drug development company focused on CMC (Chemistry, Manufacturing, and Controls). Unlike most testing labs, consulting firms, and CDMOs, we are a full-service development partner offering a unique model for seamless scale-up from bench to commercialization. We integrate formulation and analytical development, analytical and stability testing, method validation, manufacturing enablement (prototype preparation, tech transfer, GMP oversight), and stringent regulatory strategy into one cohesive offering.

We believe in more than just providing data. Our mission is to help your development programs move faster, with fewer risks, and greater regulatory confidence from early discovery through commercialization.

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Our Value Proposition

A Flexible CDMO Model

CMC Pharma is not just a testing lab and is much more than a consulting group. We are a true end-to-end partner for robust development, regulatory oversight, and long-term program success. Our one-partner model eliminates the need for multiple vendors or outside consultants, reducing handoffs, misalignment, and costly delays that often plague drug development programs. While we prefer to be a long-term partner, we also often provide ‘a la carte’ services as needed to support programs.
01

Speed, Focus & Cost-Efficiency

We enable you to generate early-stage data, produce prototypes to evaluate feasibility, and identify lead formulation candidates faster and more affordable than other partners. Unlike large CDMOs that push early-stage or small programs to the back of the line, CMC Pharma makes your program a priority from day one. Our agile lab capacity, unique RAMP production for rapid prototyping, and embedded regulatory expertise ensure fast, scientifically sound development. This focus reduces overall costs while accelerating timelines to IND, NDA, and beyond.
02

Manufacturing Enablement & Oversight

Formulation is only the beginning. We provide end-to-end CMC services to ensure that your drug product is not only scientifically robust, but also manufacturable at commercial scale under GMP standards. From process development to tech transfer and scale-up, to selecting and qualifying external CMOs, we provide hands-on oversight for compliant, high-quality, and reproducible manufacturing.
03

Embedded Regulatory Strategy

At CMC Pharma, regulatory strategy is embedded in everything we do. While early phase work can be completed non-GMP, our team integrates regulatory strategy into every data package. Our overall goal is to evaluate feasibility, mitigate risk, and move your program forward with confidence.
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Therapeutic & Specialty Areas

We partner with innovators across a broad spectrum of therapeutic areas, bringing CMC expertise to high-need fields, including but not limited to:
  • Oncology
  • Cardiovascular & Circulatory Medicine
  • Neuroscience & Mental Health
  • Endocrinology & Metabolic Diseases
  • Orthopedic & Anti-Inflammatory
  • Infectious Diseases & Immunology
  • Medical Countermeasures
  • Animal Health

We also have strong capabilities in more specialized compound classes, including controlled substances (Schedules II-IV), highly potent compounds (HPAPIs), novel or complex dosage forms, and much more.

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Our Commitment & Why Clients Trust Us

Proven Track Record

We’ve been awarded government and defense contracts, participate in major consortiums, and successfully deliver for industry partners who need solutions that work reliably.
01

Regulatory Readiness

We maintain submission-ready documentation and quality systems. Our facilities are FDA registered and inspected, and we have undergone many client audits.
02

Security & Compliance

Licensed facilities for controlled substances; systems in place for handling HPAPIs; government-approved accounting; advancing toward CMMC Level 2.
03

Exceptional Project Management

Every program gets coordinated oversight; clients benefit from a single point of accountability; issues are anticipated early; we stay aligned with your goals.
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Our Mission & Vision

Our mission is to accelerate the development of safe, effective therapies by seamlessly bridging the gap between discovery and commercialization. We leverage our deep expertise of CMC development and execution, manufacturing oversight, and regulatory strategy to offer a truly unique and flexible model tailored to each drug development program. We are committed to making drug development less risky, more predictable, and more accessible to innovators who want to make a difference.

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    Contact Us Today to advance your drug development program.

    The scientists at CMC are experts in Chemistry, Manufacturing, and Controls for all stages of the drug development cycle. Whether you need to reformulate an existing product or need help filing an NDA, we can help.

    Send us a message or give us a call at 440-485-1734