Stability Studies
Conducting rigorous testing to assess the shelf-life and storage conditions of drug products.
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Facilities & ᴄGMP Lab
Facilities and ᴄGMP Lab
At CMC Pharma, our facilities are designed to support every phase of pharmaceutical development. Our FDA-inspected laboratories are fully compliant with current Good Manufacturing Practices (cGMP), ensuring that all data generated can be utilized in regulatory submissions, including Investigational New Drug (IND) and New Drug Application (NDA) filings with the U.S. Food and Drug Administration (FDA).
These services are integral to our commitment to delivering high-quality, compliant data that supports the advancement of drug development programs.
Pilot Plant: Advancing Drug Product Prototypes
Our in-house pilot plant plays a pivotal role in advancing drug product development and allows developers to quickly evaluate product feasibility. Equipped with the necessary tools and flexibility, we prepare prototypes of solid oral, injectable, and controlled-release dosage forms. This capability allows us to:
- Develop and Optimize Formulations: Tailoring drug formulations to meet specific therapeutic needs.
- Scale-Up Processes: Transitioning laboratory-scale processes to pilot-scale production, ensuring scalability and consistency.
- Conduct In Vitro and In Vivo Studies: Providing critical data to support clinical development and regulatory submissions.
By integrating pilot plant capabilities with our cGMP laboratory services, we offer a seamless transition from formulation development to prototype preparation, expediting the drug development process.
Supporting Drug Product Development
Our facilities are equipped to handle a wide range of drug product development needs, including:
- Formulation Development: Designing and optimizing drug formulations to achieve desired therapeutic outcomes.
- Analytical Chemistry: Employing advanced analytical techniques to characterize drug substances and products.
- Drug Delivery Systems: Developing innovative delivery systems to enhance the efficacy and patient compliance of drug products.
- Process Development: Scaling up manufacturing processes from laboratory to commercial scale while maintaining product quality and consistency.
Trusted by a Diverse Clientele: From Start-ups to Big Pharma
CMC Pharma is a valued partner to a broad spectrum of clients, including:
- Start-ups and emerging pharmaceutical companies
- Established pharmaceutical and biotechnology firms
- Virtual drug development companies
- Non-profit research institutions
- Government agencies requiring specialized drug development services
We are proud to have supported numerous clients in bringing their drug products from concept to market, ensuring compliance with regulatory standards and advancing public health objectives.
How We Assist Your Drug Product Development Needs:
- Early to Late Stage Programs
- Determining an appropriate CMC development strategy
- Identifying & developing drug delivery systems (i.e. long-acting formulations)
- Completing appropriate formulation development studies
- Designing & executing stability programs
Through Post-Approval
- Formulation & process remediation
- Identifying formulation stabilizing strategies
- Developing & validating analytical methods
- Determining CQAs & CPPs and implementing proper control strategy
- Leading & assisting OOS and OOT investigations
- Determining product shelf-lives
- Troubleshooting stability failures
- Validation of processes, methods, and equipment
ᴄGMP Lab Services
- Analytical development
- Analytical method validation
- Release testing
- ICH compliant stability
- Material compatibility
The Benefits of Partnering with CMC Pharmaceuticals
At CMC Pharma, we are more than a vendor—we are a true development partner. By integrating formulation, analytical, and pilot-scale capabilities under one roof, we reduce hand-offs, streamline timelines, and help de-risk your development programs. When it’s time to scale up, we stay involved with the process and assist our clients in selecting, qualifying, and managing GMP Contract Manufacturing Organizations (CMOs).
Our collaborative approach ensures that every decision is informed by regulatory expertise and scientific insight, helping you save costs, avoid common pitfalls, and accelerate your path from concept to commercial product. When you partner with CMC, you gain a team dedicated to your program’s success at every stage, from early development through post-approval support.
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Contact Us Today and find out how CMC Pharma can help you!
Whether you’re looking for formulation development studies, analytical method development and validation, drug stability evaluation, or more, our expert team is ready to connect.
Send us a message or give us a call at 440-485-1734