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Analytical Support Services
We offer Pharmaceutical Development Services for various dosage forms such as Oral solids, Sterile Injectables and Non Sterile Liquids from our facilities in US, UK an India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct development work in parallel; accelerating time to market and reduce costs for our customers.
- Chemical: Solubility (equilibrium / kinetic), hygroscopicity, thermal behaviour, log P, stability.
- Physical: Microscopy, particle size
- Forced degradation
- Particle size
- Excipient Compatibility
- Fast content uniformity
- Analytical Methods Development / Validation / Transfer
- Clinical Supply Release
- ICH Stability studies
- Identification of unknown impurities
- Cleaning validations
ORAL SOLIDS STERILE INJECTABLES Comparator Testing: Fixed Dose Combination, Modified Release formulations Extractable and leachable studies Blend Uniformity Forced degradation studies Hardness / Friability / Bulk Density Moisture content Disintegration Residual solvent determination Moisture (KF and LOD) Cleaning validation Particle size distribution (granules) Raw material, in-process, and finished product testing Sieve fraction analysis Dissolution testing (immediate and extended release)
- Stability Studies
- In order to ensure the safety and efficacy of your drug product, Piramal currently offers stability programs with chambers covering -20°C, 2-8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data that you need for your filing.
- Analysis to Support Formulation Development
- Excipient Compatibility
- Fast content uniformity
- Bio-relevant Dissolution for formulation selection
- Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients
- Environment Monitoring of Classified Areas.
- Microbiological analysis of Water. (Testing the quality of water)
- Microbial Enumeration Test (Total number of microorganism present in product).
- Stability Studies along with Preservative Efficacy testing.
- All testing as GLP requirements.
Analytical Testing Services
- Liquid chromatography (HPLC)
- Diode array detectors (DAD)
- Refractive index detector (RID)
- Gas chromatography (GC)
- Protein concentration (TOC)
- Infrared spectroscopy
- Karl Fisher Moisture Analysis (KF)
- pH determination
- Total organic carbon (TOC)
- USP particulate testing: HIAC 9705
- Specific gravity
- Dissolution testing
- Particle size testing
- Zeta potential
This is our site for development and GMP manufacturing for complex pharmaceutical NCEs. It is located in Aurora, 50 kms north of Toronto.See Our Facility
The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building.See Our Facility
Our State-of the-Art FDA licensed cGMP facility in Riverview, USA, has over 50 years of extensive experience in delivering robust cGMP manufacturing processes..See Our Facility
Grangemouth, UK is a USFDA and MHRA approved site dedicated to the contract development and manufacturing of Antibody Drug Conjugates since 2004.See Our Facility
The Pharma Solutions Morpeth site is one-of-a-kind US FDA and UK MHRA approved facility offering integrated services across the pharmaceutical value chain.See Our Facility
Ahmedabad, India site was established in 2009. It is a MPA, Sweden approved and FDA approvable facility for development..See Our Facility
Piramal Discovery Solutions site is located in Ahmedabad, India and provides a comprehensive range of early stage drug discovery servicesSee Our Facility
Operational since 2005, our Mumbai site is fully equipped for development of all liquid dosage forms both Sterile and Non-sterile.See Our Facility
The Pithampur formulations site is a Greenfield project set in 1992 by Piramal Pharma Solutions. The US FDA and UK MHRA approved facility..See Our Facility
Ennore is identified as the India centre for development and early phase projects located near the Chennai port. The site is spread over an area of 75 acres..See Our Facility
It is a dedicated and multipurpose plant identified for custom manufacturing and development for late phase API’s and advanced intermediates.See Our Facility
It is a multipurpose plant identified for manufacturing of straight Vitamins & Vitamin Mineral Premixes.See Our Facility
SHANGHAI, CHINASee Our Facility
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.