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Clinical Trial Packaging
Clinical Trial Packaging
We offer specialized services in the area of Clinical Trial Supply management using our global network of assets, our experience and expertise in streamlining the clinical trial packaging and supply process, thus ensuring that the study drug is available where you need it and when you need it. Our advanced software, ‘Trak Pack®’, tracks the movement of the batch supplies across the supply chain..
Clinical (GMP) Manufacturing
Our pharmaceutical contract manufacturing services can support the drug discovery process through manufacturing of advanced chemical intermediates and active pharmaceutical ingredients (API) for all clinical phases.
We assist our customers to overcome a range of challenges from process development to optimizing an existing lab scale process. Further we offer expertise in GMP manufacturing of materials to support Phase I to Phase III clinical trials, as well as product registration. We always work with the goal of developing a formulation and the relevant processes that are needed for successful scale-up and large- scale manufacturing on automated equipment. Our manufacturing sites have been 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
- 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
- In additional to Human Clinical Products, Pre-Clinical to Commercial supplies of Sterile Injectables in the Veterinary segment
- 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
- Sourcing of Comparator drugs or con meds
- Proprietary web based tool, 'TrakPack', to track clinical kit status
- Adherence to U.S., EU, Japanese and other market standards
Clinical Trial Packaging
Clinical Batch Packaging involves Primary and Secondary packaging Services
- Primary packaging:
- Bottling: Solid dose bottling and multi dose blistering capabilities.
- Blistering: Hot and cold seal walleting and blister carding capabilities
- Secondary packaging:
- Artwork design
- Translation services
- Label printing
- Patient kit assembly
Clinical Trial Supply Services
Piramal Clinical Trial Supply services are streamlined to ensure timely delivery along with real-time tracking system to study the drug at right place in right time. We have shipped to more than 100 countries including Russia, Brazil and Israel in the last 5 years. Some features of our service are:
- 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.
- Integrated system TrakPack® to track and trace in real time.
TrakPack® – Manufacturing & Distribution Tracking System
TrakPack® is a proprietary, real-time, protocol tracking system used, from project initiation through to the patient kit arrival at the clinical site. TrakPack® has the following benefits
- Is a secure web-based GMP validated application
- Integrates with IVRS
- Tracks the assembly, storage and distribution to the individual kit level
- Utilizes barcode verification for key stages of manufacturing and logistics
- Has a configurable customer interface for real-time tracking
- Fully 21CFR part 11 compliant
- QP services
- 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
Process R&D Services
Pre- Formulation Studies
Analytical Support Services
Clinical Trials Services
Piramal Discovery Solutions (PDS) is a reputed service provider for mg to gm scale discovery chemistry. We have partnered with a range of well known pharmaceutical and biotechnology companies from Europe, USA and Japan.
We provide our enzyme catalyzed processes for fast track discovery and development of novel, green & economical routes to APIs.
Our capabilities harness the superior stereoselectivity, chemoselectivity and regioselectivity of Nature’s catalysts for the synthesis of complex molecules.
We have been providing pharmaceutical intermediate and API process development services for nearly three decades from our network of R∓D and manufacturing facilities across the globe. Our synergistic model of delivery across Canada, India and the UK offers the advantages of speedy drug development, proximity to markets, as well as flexible solutions. We have a team of over a hundred scientists across geographies supported by an infrastructure of fume-hoods, kilo labs, analytical instrumentation and GMP, as well as non-GMP production areas.
With very small quantities of active pharmaceutical ingredients (API) or drug-able candidate molecules, Piramal Pharma Solution’s pre-formulation service can provide valuable information and expertise to guide the compounds to next steps. Our pre-formulation team has extensive experience handling a wide range of compounds and can suggest the path forward for early success.
We offer Pharmaceutical Development Services for various dosage forms like Oral solids, Semi-Solids and Liquids (Sterile and Non-Sterile) from our facilities across UK and India. Being an integrated global solution provider we have the flexibility to simultaneously engage our facilities for conducting parallel development work to reduce the go-to-market time and costs for our customers
We offer a full range of analytical services, including analytical method development, validation and transfer, stability studies, comparator and in-process testing, from our state-of-the-art facilities and experienced scientific staff.
Piramal Corporate Regulatory Affairs, located in Mumbai, India provides expert clinical & regulatory support in all phases of global drug development programs. This includes regulatory support of New Chemical Entity’s development (NCE), Clinical Trials, Marketing products, Generics, OTC products & Medical devices
We offer specialized services in the area of Clinical Trial Supply management using our global network of assets, our experience and expertise in streamlining the clinical trial packaging and supply process, thus ensuring that the study drug is available where you need it and when you need it. Our advanced software, ‘Trak Pack®’, tracks the movement of the batch supplies across the supply chain.
Piramal facilities have the scientific capability and expertise to develop paediatric formulations meeting the age appropriate and regulatory requirements. We also offer Clinical Research Capabilities (CRO) to conduct Paediatric formulation screening studies to support scientific screening of various formulations during the development and selection stage.