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.
Clinical (GMP) manufacturing
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.
Contract manufacturing services: API
- Supply cGMP materials for clinical trials
- cGMP process validations required to support NDA approval
- Chemical, manufacturing and control data for NDA filing
Contract manufacturing services: Formulations
- 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
Salient features of GMP manufacturing
- 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
Clinical Trial Packaging
Clinical batch packaging involves primary and secondary packaging services
- Bottling: Solid dose bottling and multi-dose blistering capabilities
- Blistering: Cold and thermoform capability with hot and cold seal wallet options
- Secondary packaging
- Artwork design
- Translation services
- Label printing
- Patient kit assembly
Clinical Trial Supply Services
Our clinical trial supply services are streamlined to ensure timely delivery, along with a real-time tracking system to study the drug at the right place at the right time. We have shipped to more than 100 countries including Russia, Brazil, and Israel in the last ten years.
- Post study drug and Patient kit returns, reconciliation and destruction management.
- Complete portfolio of storage and global distribution, including controlled drug storage and shipment.
- Regulatory clinical trial application support and full supply chain certification, with dedicated depot staff.
- Protocol inventory management (using SAP) to the subject/patient kit level.
- Certification of individual batches following authorization by EU member state for clinical trial to proceed.
- QP release certificates for batch releases and re-issuance if further countries are added in the clinical trial.
- Auditing documentary evidence to support QP declaration
Returns and Destruction
- Management of post study drug returns, reconciliation and destruction