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Dedicated team and facility for separation and purification of difficult compounds
(Enantiomers, Close eluting compounds and many more)
Impurity Profiling
Project Initiation
Analytical Method Creation & Validation
Reformulation Research
Reformulation Optimization
Reformulation Development
Project Management Across Stages
Scale-up & Technology Transfer
Project Initiation
Analytical Method Creation & Validation
Reformulation Research
Reformulation Optimization
Reformulation Development
Project Management Across Stages
Scale-up & Technology Transfer
Each project begins with Project Initiation and Scoping, ensuring a clear understanding of client objectives and regulatory requirements. This is followed by in-depth Reformulation Research and Development, where innovative methods are explored to enhance efficacy, stability, and performance.
Our Analytical Method Creation and Validation guarantees precision and reliability throughout every stage of formulation. We emphasize Reformulation and Optimization to achieve superior product outcomes, backed by robust data and scientific insight. Finally, through Scale-up and Technology Transfer, we ensure smooth transition from lab to production, while our Project Management Across Stages provides seamless coordination and quality assurance at every milestone.
ICP-OES - Make/model - Perkin Elmer Optima 8000
ICP-MS - Make/model - Agilent 7800
HPLC - Make/model - Waters Alliance e2695, Waters 2489 (Arc) with UV/Vis and PDA detectors and RI detector
UPLC - Make/model - Waters Acquity UPLC H class
GC - with FID, TCD, ECD and NPD — Make/model - Perkin Elmer Clarus 580 and Agilent 7980A with HS 7694E
Stability Chambers - Newtronic
LCMS - Waters Acquity SQD2
| CATEGORY | TECHNIQUES / INSTRUMENTS |
|---|---|
| CHROMATOGRAPHY | HPLC, UPLC, GC |
| SPECTROSCOPY | UV-Vis, FTIR, ICP-MS, ICP-OES, LCMS |
| WET CHEMISTRY | pH, Conductivity, Titrations |
| DISSOLUTION | Dissolution & Disintegration Testing (USP (711)/(2040)) |
Mini Rapid Mixer
Granulator GMP Model
Duo Press – Bilayer
Tablet Press
Sieve Shaker
Octagonal Blende
Fluid Bed Dryer
Homogenizer
Ointment Filling
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FB Tech CI (Lab Model) - Fluid Bed Processor
Pre-formulation studies evaluate the physical and chemical properties of an API before dosage form development. These studies help predict stability, solubility, compatibility and formulation behaviour, reducing risks during manufacturing and regulatory stages.
Analytical development typically applies HPLC, LC–MS, GC, dissolution, spectroscopy and impurity testing. These methods confirm identity, purity, degradants and overall pharmaceutical quality throughout formulation development.
Stability testing exposes a product to controlled humidity, temperature and light to study degradation over time. This determines shelf life, storage conditions, packaging suitability and long-term safety.
Formulation generally follows FDA, EMA, WHO and ICH Q guidelines including Q8, Q9 and Q10. These standards ensure scientific justification, validated methods and quality risk management through the development lifecycle.
Impurity profiling identifies and evaluates degradation products, organic impurities and residual elements. It helps ensure patient safety, regulatory acceptance and long-term pharmaceutical quality.
Excipients are selected based on API characteristics, stability, solubility, compatibility, dosage form requirements and regulatory acceptance. They also support manufacturability and release profiles.
Timelines vary depending on API complexity, dosage form and regulatory pathway. Generic formulation may take a few months while NCE development requires extensive research and may take several years.
Yes. Generic development focuses on equivalence and existing standards, while NCE formulation requires additional characterization, analytical development and long-term stability evaluation.
Solubility influences absorption, particle size affects dissolution and polymorphism impacts stability and process performance. These properties shape dosage form selection and bioavailability.
Method validation includes precision, accuracy, specificity, linearity, robustness and detection limits. Validated methods ensure reliable measurement and regulatory compliance.
Common challenges include poor solubility, polymorphism, instability and excipient incompatibility. These are addressed through screening studies, analytical development and formulation optimization strategies.
