Formulation and Process Development & Technical Transfer
Developing robust and reproducible manufacturing processes with comprehensive process understanding and controls is critical to the success of your development program
Our highly-skilled development team enables us to provide a maximum level of service and competence for every single project.
- Depth of scientific knowledge applied to your project
- Direct, fast communication through your dedicated project manager
- Flexible approach to your evolving needs
- QbD approach
- Consistent high quality to EMA, FDA
Analytical Development
Through the integration of our drug development, clinical supply and manufacturing expertise our depth experienced group of analytical scientists can undertake the comprehensive array of Analytical and Microbiological test methodologies to assure a fast, flexible and accurate solutions across a broad range of services:
- Analytical Chemistry for raw materials, bulk and finished products
- Qualified Person Release
- Method development, validation and transfer
- Microbiology & Sterility testing
All to a consistent high quality according to EMA, FDA regulations.
These services are key components of a global development and clinical packaging offering with a Wide range of quality testing services to support drug research, registration and production
We are proud that our teams contribute to our customers success
Stability Studies
Comprehensive stability storage facilities able to support small bespoke stability studies through to large pivotal programmes.
Deep experience of development pharmaceutics, device verification testing and authoring of CMC sections for regulatory submissions.
Regulatory Support
Our regulatory experts will do more than write the narrative for your approval. We will work hand-in-hand with you to build a robust and flexible regulatory strategy and proactively address problems surrounding scalability, supply chain, and global regulatory requirements.
CPL supports our customers in the development and registration phases of their products, with particular expertise in scientific regulatory affairs and registration documentation.
CPL regularly delivers the following services:
- Co-ordination of the compilation of the CMC section (CTD Module 3, QOS Module 2.3, IMPD)
- Reformatting and updating of Dossiers
- Variations preparation
- Submission and follow-up of procedures
We also support the submission of INDs, NDAs and ANDAs in the USA
