The CUSTOpharm Program is our turnkey product development program combining all of our services to simplify things for our clients. With this program our clients select a drug product that they would like to have developed commercially in the US and/or abroad. CUSTOpharm then works with drug substance suppliers development labs and manufacturers to determine the most cost effective development plan and costs for commercial production.
The CUSTOpharm Program combines the following services as needed into a full-service package:
- Determination of an appropriate Product Development Plan
- Sourcing of Product Manufacturing/Contract Manufacturing
- Technology Transfer from the lab to the manufacturer
- Project Management to ensure timelines are maintained and problems averted
- Preparation of the Regulatory Filing in the eCTD format
- Managing the approval process through tracking the submission progress
- Responding to deficiencies in a timely fashion
- US Agent Service (if needed)
CUSTOpharm oversees the analytical and formulation development, manufacture of the stability/qualification batch(es) and stability testing. CUSTOpharm then prepares and files an FDA submission in the eCTD format. The final product of this service is an approved drug product. If desired, this service can be extended to oversee the process validation of the drug product. The degree of client involvement and details in the product development and regulatory processes/procedures can be modified to suit our clients’ needs.
The CUSTOpharm Program enables our clients to focus on clinical and commercialization activities instead of being distracted by the CMC product development.