All of our studies are conducted in total confidence and we comply with the latest recommendations from the FDA, ICH, CPMP, and Indian Ministry of Health and Family Welfare. All assays are performed under full compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. We have formed strong partnerships with many of the world’s leading biopharmaceutical and biotechnology firms; many biological now licensed by the FDA, EMEA and other international agencies have been tested and validated by LifeTech

·         Active Pharmaceutical Ingredient Manufacturing:  Our expertise in organic synthesis and process development complemented by a controlled supply chain enables us to provide our customers with high quality Bulk Actives at competitive prices. We are aggressively building our product portfolio to cater to generic players in the emerging markets and generic and patent challenge formulators in regulated markets. 

 

·         Our API business is supported by our technologically advanced Product Development infrastructure, which identifies new products and is engaged every step of the way, from the conceptual stage to delivery of drugs to the market place. The Product Delivery Teams, the Centers of Excellence and IP teams help create value through Intellectual Property and proactive patenting; early development work on certain promising molecules; breakthrough product delivery; and by delivering cost leadership in API. 

·         Biologics Safety Testing: Provide biological safety assessments from testing to present-day gene therapies. Our capabilities include a broad spectrum of cGMP- and GLP-compliant biosafety, virology, immunochemistry, molecular biology and microbiology testing services. 

·         Testing & Clearance: Conducting viral clearance studies to assess the ability of the manufacturing process to produce a product that is safe for use in humans. Many biologics such as plasma derivatives, monoclonal antibodies, recombinant proteins and medical devices. 

·         Manufacturing Services: Production of viral therapeutics, cell therapeutics and microbiologically expressed protein products using current Good Manufacturing Practices (cGMPs) and production facilities with extensive technical and regulatory expertise provide the support you need for efficient product development and the guidance you trust to achieve regulatory approval worldwide. 

·         Toxicology Services: Provide GLP compliant genetic, in vivo and molecular toxicology testing on pharmaceutical, biopharmaceutical, and medical device or pesticide products. Our scientific staff and state-of-the-art facilities provide the most complete and comprehensive toxicology resources available anywhere. We are recognized internationally for our experience in the successful management and performance of multidisciplinary biomedical and toxicological research projects. 

·         Analytical Services: Provide analytical services involve the testing of biotechnology products to show that their molecular structure meets predefined criteria and that the macro-molecules remain safe, stable and efficacious in the final product formulation. In these studies, the product is physiochemically characterized using a variety of standard and state-of-the-art analytical methods. 

·         Laboratory Animal Services: Provide Laboratory Animal diagnostic services for all of your testing needs, offering a complete spectrum of animal diagnostic and analytical services for both routine monitoring and emergency situations. 

·         Clinical Trials Support Services: Provide Clinical Trial Support Services with significant experience in the manufacturing and testing of viral vectors and vaccines. Clinical trials with viral vectors and vaccines may require additional tests beyond the standard clinical chemistry and hematology required for other clinical trials as a Clinical Research Organization.

·         Support Services: In a fast changing global economy, our Quality Systems, Project Management and Client Services, Regulatory and Technical Support facilities to help clients move their products to market in the fastest, most efficient manner. We also set the highest quality and customer service standards for all our clients' projects.