Welcome to C-Trials Global Inc.
Formulation & Ready Dossier Services
Our Services
Contractual Formulation Development and Ready Dossier Services
Contractual Formulation development and Ready Dossier Services.
- C-Trials Global Inc. is capable of giving a complete solution for your Formulation & Development needs
- Once the sponsor identifies the molecule, strength and dosage form we can give complete time bound quality service from API sourcing right up to dossier filling. We can also give manufacturing options from an USFDA approved manufacturing unit from India.
- API Sourcing from DMF holder
- Undertaking Trial Lab Scale Batches
- Finalization of Lab scale finished product development
- Analytical Method development and Validation
- Exhibit Batch manufacturing from USFDA approved manufacturing unit
- Performing Stability studies up to 6 months in different conditions
- Lab Scale Trial Batches
- Scale Up Batch manufacturing from a USFDA approved manufacturing unit
- Performing Bio Equivalence Study against specified RLD/ Innovator based in USA
- Tech Transfer to manufacturing unit in USA or the place where the sponsor asks us.
- Tech Transfer to our partner manufacturing unit in India which is USFDA approved
- Complete dossier filing M1 – M5.
- Coordinating with the USFDA post submission till the marketing approval is received
- If the sponsor selects our partner USFDA approved manufacturing unit, coordinating the timely manufacturing and logistics of the end product from India to USA/ any other country.