Our veteran team has the knowledge and expertise necessary to guide you through the development process.
Let our drug development expertise work for you whether we manufacture your product or not
The road to developing a new pharmaceutical product can be a long and arduous one. There are so many factors that can impact the timeline for your project, including regulatory hurdles and manufacturing challenges. Any one of these issues can lead to serious delays in your quest to enter the market, potentially increasing your costs and causing you to lose ground to the competition. This is why having the experts from CritiTech Particle Engineering Solutions to provide CMC consulting for your project can lead to better results for you. With quality CMC consulting provided by our team of specialists, you can navigate the complexities facing you and achieve better results.
Having an expert at your side not only makes you feel more confident about your project, but it helps to save time and rework to get you to ultimate success more quickly. With our team of proven experts who have been down this road a number of times, we can help you navigate the barriers and complexity of regulatory requirements in pharmaceutical development. We will partner with you on individual aspects where you need assistance, or we can provide full management of the process for you.
CMC Consulting Services
We offer you a single source for all the expertise and knowledge you need to guide your drug to market as successfully as possible. The experience of our CMC consultants in pharmaceutical development means we can help you anticipate all the challenges you can encounter. From optimizing your manufacturing procedures to ensuring regulatory compliance, we’re committed to helping you create a smooth, efficient and compliant pathway that can bring your drugs to market faster and with minimal risk.
- CMC Project Management and Planning
- CMC Project Management Team
- Formulation
- Analytical
- Manufacturing
- Process Development
- Scale-up
- Analysis and Selection of CDMO’s and CRO’s
- Develop Network of Drug Development and Manufacturing Suppliers and CRO’s
- Authoring and Reviewing CMC Regulatory Filings (IND’s, NDA’s, FDA queries, supplements and amendments, annual reports, site inspections observations, 483’s and warning letters)
- Product Development
- Product development strategy
- Participate as members of the product development team
- Process Design, Validation and Troubleshooting
- OOS and OOT investigations
- Stability programs and failures
- Sterility failures
- Validation of processes, methods and equipment
- Compliance with cGMP Requirements
- Drug Product Instructions
- Dosage preparation instructions
- Technical Business Support
- Support due diligence efforts of investors, licensees, buyers, M&A activities
- Assist with preparation of presentations
Why Choose CritiTech?
Choosing our CMC consulting services can provide your company with the smoothest possible path to the market. Our team has the experience and proven track record of success to help our clients overcome their challenges and complete their journeys. We strive to be a true partner to every client we serve, providing personalized attention based on a deep understanding of their needs and how they define success. If you want to learn more about all the capabilities we can provide for you and your next project, reach out and speak with a member of our team today.