Piramal - Clinical Trial Services
We offer specialized services in clinical trial supply management using a global network of assets, experience, and expertise in streamlining the clinical trial packaging and supply process, thereby ensuring that the study drug is available as needed.
Our pharmaceutical contract manufacturing services support the drug discovery process through the manufacturing of advanced chemical intermediates and active pharmaceutical ingredients (API) for all clinical phases.
We assist our customers with services ranging from process development to optimizing the existing lab-scale process, with expertise in GMP manufacturing of materials to support Phase I to Phase III clinical trials, as well as product registration. We always work to develop a formulation and the relevant processes for successful scale-up and large-scale manufacturing on automated equipment. Our manufacturing sites are successfully inspected by numerous regulatory agencies, including the US FDA and EU EMA.
- Supply cGMP materials for clinical trials
- cGMP process validations required to support NDA approval
- Chemical, manufacturing and control data for NDA filing
- Product capabilities
- A comprehensive range of solid dosage forms
- Liquid and lyophilized parenterals
- Control drug substances
- Potent compounds such as Hormones, Oral Contraceptive Pills (OCPs), and cytostatic compounds
- Manufacturing of drug product and matching placebos
- Quality by design process development
- Manufacturing, packaging, and release testing
- Chemistry, Manufacturing, and Controls (CMC) documentation for your IND or NDA
- Over-encapsulation of tablets or capsules
- Product blinding and comparator sourcing
- Adherence to the US, EU, Japanese, and other market standards