Facilities & ᴄGMP Lab
Facilities and ᴄGMP Lab
Our facilities are designed to support every phase of pharmaceutical development, putting the necessary emphasis on early-stage CMC activities. 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
- 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
- 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
- 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
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 Include:
- Analytical development
- Analytical method validation
- Release testing
- ICH compliant stability
- Material compatibility
The Benefits of Partnering with CMC Pharmaceuticals
We take pride in being more than a vendor. Instead, we act as a true development partner that is focused on protecting your program. 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.
Send a message
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