Analytical Solutions
Analytical Research and Development involves pre-formulation, stability and degradation studies on APIs and other drugs, and preparation of technical dossiers for registration in India and other countries. The Analytical Development team provides specific services to various departments of Seemax Biotech Research Center.
Seemax Biotech offer a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds. We also perform stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.
Seemax Biotech team is capable of providing documentation support – CMC, IND-CTA, MAA and DMF in line with the regulatory requirements across the globe. Equipped with one of the best infrastructures in India for Analytical services, SEEMAX BIOTECH is well positioned to meet the needs of complex analytical challenges.
Our Capabilities:
- A wide range of chromatographic separation techniques (HPLC, UPLC, GC, SFC and IC) and detection techniques (UV, FL, MS, ELSD, RI, FID, TCD, CAD, etc.) to meet the requirement of different types of compounds including the ones that are non-chromophoric in nature.
- Stability-indicating assay and/or related substances methods for drug substances & products (stress stability testing as per ICH).
- Dissolution (IR, ER and MR)
- Residual solvents by HSGC
- Enantiomeric separation by normal phase HPLC & GC
- Clinical comparator assay and dissolution
- Method development, qualification, validation and transfer
- Release and in-process testing
- Stability protocol development and program management
- Stability storage, testing and data trending
- Compendial testing (USP, EP, BP, JP, etc.)
- Microbiological testing
- Analytical support for cleaning validation & process validation
- Isolation of impurities and purification of compounds using Preparative LC & SFC