FAQ
CMC Pharma frequently receives questions about our capabilities, processes, and partnerships. Below, we’ve answered common client questions to help you understand how we can support your drug development program from concept to commercialization.
Drug Product Development & Dosage Form Design
We design and develop a wide range of dosage forms, including solid oral tablets and capsules, injectable solutions, controlled-release formulations, and more. Our expertise also extends to complex and long-acting formulations.
Yes. We support programs from early-stage formulation and analytical development through pilot-scale production, stability testing, and preparation of regulatory documentation to enable commercialization.
We work with a qualified network of Contract Manufacturing Organizations (CMOs) to identify the most appropriate facility for production of your drug substance and/or drug product. While we do not conduct discovery research, we provide full-service formulation, analytical, and pilot-scale development support. Our role is to de-risk programs, optimize formulations, and prepare drug products for regulatory approval and clinical use.
Yes. CMC Pharma specializes in improving bioavailability and solubility through advanced formulation strategies, including through solubilization techniques and controlled-release technologies.
Our team evaluates and redesigns formulations to enhance stability, prevent degradation, and extend product shelf life while maintaining efficacy and safety.
We have experience developing combination drug products, optimizing compatibility, stability, and release profiles for multiple active pharmaceutical ingredients (APIs) in a single formulation.
Yes. CMC Pharma has the facilities, expertise, and safety protocols required to handle highly potent, cytotoxic, and controlled substances safely and effectively throughout development and testing.
Drug development generally includes preclinical research, formulation development, clinical trials (Phase I–III), regulatory submissions, and post-approval lifecycle management. We primarily support CMC-focused development activities across these stages.
CMC & Regulatory Services
CMC services encompass all aspects of drug product development and manufacturing controls, including formulation design, analytical method development, stability testing, process development, and documentation needed for regulatory submissions. CMC ensures the safety, quality, and efficacy of the finished drug product.
Yes. Our team develops and validates analytical methods to ensure accurate, reproducible results suitable for regulatory filings.
Absolutely. We generate comprehensive, FDA-ready documentation to support IND, NDA, and other regulatory submissions.
Facility & ᴄGMP Services
Yes. Our laboratories are fully cGMP-compliant and capable of generating data for regulatory submissions. We conduct a range of cGMP testing, including stability, release testing, analytical method validation, and more.
We primarily provide development and pilot-scale prototype production services, and do not operate large-scale commercial manufacturing. We support scale-up and technology transfer to commercial manufacturers, and our unique Manufacturing Oversight includes CMO selection, qualification, and management.
Yes. We assist in evaluating potential CDMOs, qualifying secondary sites, and providing oversight to ensure your product is developed and manufactured to required standards. We’ll even execute the quality agreements on your behalf. We then provide ongoing analytical support, including batch release testing.
Analytical, Stability & Testing Services
We provide ICH-compliant stability studies, in-use and custom stability studies, photo-stability testing (UV and visible light), and shelf-life improvement strategies.
Yes, we design and execute full ICH-compliant stability studies to determine and document drug product shelf life.
Yes. Our formulation scientists develop stabilizing strategies tailored to your drug product’s unique challenges.
Yes, we provide dissolution testing to assess drug release profiles and support formulation optimization. We have Dissolution Apparatus II (Paddle) and IV (Flow-Through).
Yes, we conduct these studies to ensure packaging materials do not compromise product quality. We do not provide any microbiology testing services at our facilities, but routinely subcontract these services to qualified vendors.
Yes, we can simulate shipping conditions to validate product stability during transport.
CMC Pharma designs and executes forced degradation studies to identify potential degradation pathways, characterize impurities, and support formulation stability and regulatory submissions.
Our analytical team performs comprehensive impurity profiling, including identification and quantification of degradation products, ensuring your drug product meets quality and regulatory standards.
Yes. We provide full support for analytical method transfer, including documentation, training, and validation, to ensure that methods are accurately and reproducibly implemented at partner labs or commercial manufacturing sites.
Formulation & Prototype Services
Yes. We specialize in overcoming solubility and stability challenges for difficult APIs.
Absolutely. Our expertise includes long-acting injectables, controlled-release oral formulations, and other complex dosage forms. We have extensive experience in developing in situ forming drug delivery depots. The formulation gels upon injection, and release is prolonged by diffusion from the in situ gel, followed by polymer degradation. We have experience in developing formulations to tailor release kinetics from days to months.
Yes. We design and perform in-use studies to simulate real-world usage conditions.
Yes. We help transition formulations from lab to pilot scale and support process changes while maintaining product quality and compliance.
Pilot Plant & Manufacturing Support
CMC Pharma’s pilot plant allows seamless scale-up from lab-scale formulations to pilot-scale batches. We optimize processes to maintain product quality, consistency, and manufacturability, providing critical data to support clinical or commercial production. We effectively bridge the gap between lab bench and commercial scale.
Yes. We guide the transfer of formulations, analytical methods, and processes to commercial manufacturers, ensuring smooth hand-offs, reproducibility, and regulatory compliance.
We assist clients in evaluating potential CDMOs, qualifying manufacturing sites, and establishing robust oversight to ensure that your product is developed and manufactured to the highest standards. We provide man-in-plant services, oversight, and even execute quality agreements.
Yes. Our team provides scientific and technical support to identify root causes, implement corrective actions, and optimize processes, reducing risk and maintaining product quality throughout development and scale-up.
Proposal & Turnaround
Typically, we need details about the drug product, dosage form, stage of development, anticipated studies, and desired regulatory endpoints. Additional specifics, such as target release profiles or analytical methods, help us tailor our proposal.
Turnaround times vary based on study type and complexity. Standard stability or analytical projects generally take a few weeks, while pilot-scale or custom studies may require longer timelines. We work closely with clients to establish realistic schedules.
We take pride in our ability to quickly kick off programs, which our clients view as a significant advantage. From initial contact, our Business team quickly works with you to execute any necessary legal paperwork (CDAs, Master Services Agreements, Quality Agreements, etc.) and typically submits a quote within one week. From there, we can quickly make any necessary proposal revisions and kick off the program, typically within the month.
Specialized Capabilities
Yes. We have the necessary licenses and expertise to handle controlled substances (schedule II-V) safely and compliantly.
Yes, we have been both a sub and prime contractor to the US government on many multi-year programs. We are a trusted vendor with exceptional project management, have approved accounting systems, and are on track to be CMMC Level 2 certified by mid-2026.
Yes. CMC Pharma has extensive experience developing complex and novel dosage forms, including long-acting injectables, controlled-release oral formulations, and other challenging drug delivery systems. Our team applies advanced formulation strategies to overcome solubility, stability, and bioavailability challenges, ensuring that even the most difficult APIs can be successfully developed and tested.
Yes. We have supported the development and testing of combination drug-device products, leveraging our analytical and stability capabilities. This includes rigorous method development and validation, stability studies, and regulatory documentation to ensure device and drug components perform safely and effectively together.
What Makes CMC Unique?
CMC Pharma integrates formulation, analytical, and pilot-scale capabilities under one roof, reducing hand-offs and potential errors. Our scientists proactively identify challenges, optimize processes, and generate regulatory-ready data at every stage. This integrated approach minimizes delays, reduces costs, and de-risks programs from early development through post-approval support.
Our pilot plant and cGMP laboratories work together seamlessly. Formulations developed in our lab can be prototyped and scaled in our pilot plant without leaving the facility, providing rapid feedback on manufacturability, stability, and analytical performance. This tight integration ensures faster iteration, earlier problem detection, and smoother technology transfer to commercial manufacturing. Prototypes produced are ideal for animal testing, evaluating stability, and often lead to the client selecting lead formulation candidates.
CMC partners with a wide range of clients, including:
- Emerging biotech and start-ups needing full-service drug development support
- Established pharmaceutical and biotech companies requiring complex formulation or analytical expertise, or added capacity
- Virtual drug development companies seeking integrated CMC solutions
- Other CDMOs and CMOs collaborating on specialized projects
- Non-profits and government programs needing regulatory and development support
By working across diverse client types, we’ve built extensive experience addressing common pain points in drug development, such as solubility and stability challenges, capacity constraints, and regulatory readiness.
Yes. CMC Pharma frequently partners with other CDMOs, CMOs, and industry peers to provide specialized capabilities that complement their services. Our flexible, integrated approach allows us to fill gaps, troubleshoot challenges, and jointly advance complex development programs.
Absolutely. Beyond executing development tasks, we work closely with clients to design efficient programs, optimize formulations, streamline analytical workflows, and identify potential pitfalls early. This proactive guidance reduces risk, shortens timelines, and helps manage costs across the development lifecycle.
Every program is unique, and we tailor our approach to meet specific project needs. From selecting the right formulation strategy to designing custom stability studies, scaling up processes, or preparing regulatory-ready documentation, we adapt our services to align with your goals and constraints. While we prefer to be a long-term partner, we also routinely provide services a la carte.
Yes. We actively explore co-development and collaborative research projects. Whether it’s partnering on novel formulations, drug-device combinations, or complex analytical challenges, we bring our scientific expertise, cGMP facilities, and pilot plant capabilities to support joint innovation.
Have a question not listed here? Contact our team today to discuss your program and explore how CMC Pharma can be your integrated development partner.
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Contact Us Today and find out how CMC Pharma can help you!
Whether you need to develop robust analytical methods or require routine testing, Contact CMC Pharma to learn how we can help you advance your development program.
Send us a message or give us a call at 440-485-1734