Formulation Science & Analytical Excellence
Our dedicated R&D laboratory, recognized by the Department of Scientific & Industrial Research (DSIR), is staffed by veteran formulation scientists specializing in complex effervescent reaction chemistry, bioavailability enhancement, organoleptic taste-masking, and innovative drug delivery systems.
From pre-formulation feasibility studies to pilot-scale technology transfer, we deliver comprehensive analytical method development, stability studies under ICH conditions (Zones I–IVb), and complete CTD-ready documentation for global regulatory submissions.
R&D Competencies
Our formulation lab covers the full spectrum of pharmaceutical development — from molecular screening to commercial-scale technology transfer.
Effervescent Reaction Chemistry
Proprietary TechnologyProprietary acid-base stoichiometry optimization for rapid, residue-free dissolution with consistent gas evolution profiles across varying temperature and humidity conditions.
Taste-Masking & Organoleptics
Compliance FocusAdvanced flavour-masking systems for bitter APIs using cyclodextrin complexation, ion-exchange resins, and proprietary coating technologies with sensory panel evaluation.
Analytical Method Development
ICH Q2(R1)Comprehensive method development and validation for assay, dissolution, impurity profiling, and stability-indicating methods using HPLC, UV-Vis and GC instrumentation.
Regulatory Documentation
CTD Module 3Complete CTD Module 3 & eCTD preparation with stability data packages, analytical validation reports, BMRs, Site Master Files, and Drug Master File authoring.
Development Workflow
A structured 6-stage product development lifecycle from initial feasibility through commercial launch, designed for speed and regulatory compliance.
Pre-Formulation & Feasibility
Phase 01: ScreeningAPI compatibility screening, excipient selection, preliminary stability, and dose-form feasibility assessment under controlled humidity.
Formulation Optimization
Phase 02: DOE LabDOE-driven optimization of disintegration time, hardness, dissolution profile, and taste-masking parameters with statistical analysis.
Analytical Method Development
Phase 03: ValidationStability-indicating HPLC methods, dissolution method development (USP apparatus), and impurity profiling per ICH guidelines.
Pilot Batch & Scale-Up
Phase 04: Tech TransferTechnology transfer to pilot-scale equipment with process parameter optimization, in-process controls, and batch record development.
Stability Studies (ICH Zones)
Phase 05: ICH Q1ALong-term (25°C/60%), intermediate (30°C/65%), and accelerated (40°C/75%) stability studies per ICH Q1A–Q1E guidelines.
Dossier Compilation & Filing
Phase 06: CTD Module 3Complete CTD/eCTD dossier preparation with Module 3 quality documentation ready for health authority submission across global markets.
Have a Formulation Challenge to Solve?
Our formulation scientists are ready to evaluate your API, conduct feasibility studies, and propose a tailored development timeline with full CTD regulatory dossier support.