Discovery Chemistry for
Pharmaceutical Testing
We support pharmaceutical innovators through every phase of drug development, from molecular discovery to full CMC (Chemistry, Manufacturing & Controls) characterisation.
Backed by cGMP infrastructure, GLP-compliant practices, and all encompassed analytical instrumentation, we help clients establish data integrity, product quality, and regulatory readiness across the development continuum.
With deep expertise in small molecules, biologics, and complex formulations, our scientists design and validate processes that are robust, scalable, and compliant with ICH, USP, EP, and FDA expectations.
Necessity of Discovery Chemistry in Pharmaceutical Testing
Here’s why discovery and CMC testing are indispensable in pharmaceutical development:
Ensures Quality by Design
Establishes critical quality attributes (CQAs) and control strategies from early development, reducing variability and ensuring consistency.
Accelerates Regulatory Approvals
Provides validated scientific data aligned with ICH, FDA, and CDSCO requirements for global submissions.
Optimises Formulation Performance
Identifies the most stable and efficacious formulation through advanced solid-state and excipient compatibility studies.
Guarantees Product Stability
Determines shelf-life and degradation pathways under ICH-compliant conditions, ensuring patient safety and commercial reliability.
Supports Tech Transfer & Scale-Up
Bridges R&D and manufacturing with reproducible, GMP-ready data that ensures seamless product commercialisation.
Areas of Expertise
Specialised & Routine Testing
- Enzyme activity assays (standardised QC panels)
- Heparin potency and purity testing
- Low Molecular Weight Heparin (LMWH) assays, including Enoxaparin
- Full compliance with USP, EP, and BP specifications
Batch Release & Stability-Indicating Methods
- Routine QC testing and Certificate of Analysis (CoA) generation
- Validation of stability-indicating analytical methods
Chiral Analysis & Purification
- Enantiomeric purity assessment and resolution
- Chiral LC method development and preparative purification
Analytical & Bioanalytical Chemistry
- Analytical method development and validation (ICH Q2)
- HPLC, UPLC, GC, GC-MS, LC-MS/MS, and CE techniques
- Impurity profiling, quantitation, and structural elucidation (qNMR, HR-MS)
- Residual solvents and elemental impurities (ICH Q3C / Q3D)
- Dissolution, content uniformity, assay, and potency testing
Container/Closure & Stability Studies
- Container–closure compatibility
- Extractables and leachables studies for parenteral products
- ICH-compliant accelerated and long-term stability studies
- Forced degradation studies for stability-indicating methods
Solid-State & Formulation Science
- Salt and polymorph screening
- Particle engineering and solid form selection
- Pre-formulation and formulation development for oral (IR/MR), parenteral (sterile/lyophilised), inhalation, topical, and transdermal delivery systems
- Excipients selection and compatibility evaluation
API Process Development & Scale-Up
- API synthesis, optimisation, and process development
- Pilot and GMP-scale API manufacturing
- Technology transfer to manufacturing facilities