Formulation Research and Development
Strategical, time-bound technology-driven Product Development team would deliver Stable, Clinically Safe and Effective Product by Design of robust manufacturing process with respect to Commercial Scale. The team of Scientist gathered with a wide range of expertise to cater the Products with High Acceptance of Regulatory Agencies. The Richness in Talent Pool reflects in the Development of Products with High Barrier to Entry, Highly Unstable Molecules, Non-Infringing Strategies and P(IV) Designated.
Our Successful Development would comprise a Systematic Approach of Basic understanding of molecule behaviour, identification of suitable process, legal requirements, regulatory needs, extensive process challenges with respect to Critical Quality Attributes (CQA), Optimization through Design of Experiments (DoE) with associated risks, clinical correlations, technology transfer and also includes Validation of Manufacturing Process from Bench Scale to Shop Floor.
Analytical Research and Development
Round-the-clock support of Analytical Team accelerates the Development Strategies using Organic and Inorganic Analytical Tools. The Eminent Group of Scientists working towards the results of High Resolution through three different disciplines i.e. Development, Validation and Method Transfer.
Our Team is familiar with chromatographic separation techniques (HPLC, UPLC, GC, SFC, and IC) with detectors (UV, FL, MS, ELSD, RI, FID, TCD, CAD, etc.) to meet the requirements of different types of Drug molecules with chromophore, non-chromophore and enantiomers.
Stability-indicating Method Development for Assay and Related Substances for Drug Substances & Drug Products (stress stability testing as per ICH) and Dissolution profile (IR, DR and MR), Residual solvents by HSGC are all part of our Comprehensive Analysis.
The team provides, Stability Protocol Development, Stability Storage, Testing and Data Trending, Microbiological Testing and Cleaning Validations to enable ready for Method Transfer to the QC sites with the release, in-process and stability testing specifications as per ICH & cGMP requirements.
Global Regulatory Affairs
Theragen Lifesciences understands the importance of Global Regulatory Strategies in the ever-evolving Regulatory environment. The Team has a strong track record in Product Registrations with various Regulatory Agencies. Theragen focuses to meet the High-Quality Standards of Global Regulatory Agencies like US FDA, EMA, ANVISA, HEALTH CANADA, TGA, MHRA, MCC and other Emerging markets. Key functions of the Team includes Licencing, Vendor suitability, Technical Dossier Compilation in ECTD/ACTD formats, Deficiency Handling to meet Product Approval & Product Life Cycle Management.
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