What We Do
We know every client is unique, that’s why we offer bespoke CDMO services catered to their specific requirements. With advanced technology isolators in a cGMP Annex 1 compliant facility, and exceptional Quality Assurance and Quality Control Systems, we don’t just meet our clients’ expectations – we exceed them.
cDmo = Development +
From the bench to the patient
We spare no expense to make sure everything runs smoothly during tech transfer. We help our clients with the initial burden of method and process development during the feasibility study with scalability and analytical testing. From your product's infancy and formulation all the way through its commercialization, we have the flexibility to serve your needs.
Small Scale Clinical Manufacturing
A Dedicated Suite for Phase 1 and Phase 2 Filling
GCM Pharma's dedicated suite for small scale manufacturing has the flexibility to fill your company's needs. Our clean room is designed with the latest requirements for global distribution (ANNEX 1), with an aseptic isolator, utilizing flexible filling with containers of choice. GCM can reliably produce your early stage clinical therapies when you need them - without a long lead time.
Fully Automated Fill Finish, Clinical and Commercial
Flexible Fillers to Solve Our Clients' Needs
GCM Pharma utilizes flexible, fully automated fillers for presterilized, nested, depyrogenated vials, syringes, or cartridges. Available for both Phase 3 trials and commercial quantities, carrying clients through the product life cycle saving time and money by avoiding tech transfer. Using an aseptic isolator to ensure the highest levels of quality control and sterility assurance, we offer our clients the capability to fill biologics and small molecules, with lyophilization available as well.
Other Services
Full Circle Support
- Analytical Chemistry & Microbiology Testing
- Regulatory Filing
- Labeling & Packaging Design
- Clinical Trial Repackaging
- Temperature Controlled Storage and Distribution
