Research & Development Lab is adequately equipped to facilitate Quality and Efficient development work. The built facility in Oragadam, Chennai, has pharmaceutical testing laboratory infrastructure incorporating state-of-the-art equipment providing capabilities in designing Parenteral & Oral Solid Dosages Formulations (Oncology and Non-Oncology).
Our R&D team is familiar with all the latest Pharmaceutical development design approach applying “Quality-by-Design” principles, ensuring design efforts translate into a more successful product scale-up. Through our network will to manage the execution, and global regulatory submissions.
Our team has sound knowledge and rich experience in development of multiple dosage forms comprising Tablets, Capsules, Injectables(Liquid, Lyophilized, PFS, Complex Injectable & etc). Our team has rich experience in product development right from concept design to ultimate drug product approval and commercial supply for various regulatory agencies like USFDA, MHRA, TGA and other emerging markets.
Our team is experienced in developing and filing F2F, PIV, Non-infringing formulations & etc.
- Formulation Development Capabilities
- Analytical Development Capabilities
- Stability Studies Testing Capabilities
- Parenteral & Oral Solid Dosages Formulations (Oncology and Non-Oncology)
- Dedicated area with isolator to handle potent molecules.
Dosage form development incudes:
- - Aqueous Injections
- - Non-Aqueous Injections
- - Lyophilized Powder for Injections
- - Oral Solid Dosages Formulations
- - Tablets
- - Hard Gelatin Capsules
- Analytical Method Development for Drug Substances & Drug Products
- Analytical Method Verification for Raw Materials & Drug Substances
- Analytical Method Validation for Drug Products
- Analytical Method Transfer for Drug Substances & Drug Products
- Real time, Intermediate and Accelerated chambers
- Stability testing (All ICH Zones)
- Stability monitoring through Protocol
- Data monitoring
- Stability testing reports