On June 30, 2024, Dr Vinod P. Shah, a former US FDA official and Pharmaceutical Consultant, inaugurated the new Ortiv Q3 Formulation Development Lab in Ahmedabad, alongside, Dr L. Ramaswamy, Chairman & Managing Director of Sotax India, and members of the Board of Directors of Ortiv Q3.
The ceremony was graciously attended by distinguished international luminaries like Dr Nikkoletta Fottaki from university of Bath. UK, Dr Matthias Wacker from University of Singapore. Dr Deirdre D Arcy , from University of Ireland Dr Susann from Netherlands and other dignitaries and heads of leading Pharma companies and leaders like Vijay Kshirsagar, Dr Rajiv Desai, and many others who also participated in the inauguration function.
Ortiv-Q3 provide a complete suite of contract research and testing services for a variety of dosage forms ranging from conventional to complex drug products. The fully cGMP compliant analytical setup is equipped with a wide range of state-of-the-art instrumentation and experienced technical staff capable in developing and validating analytical methods, Q2/Q3 characterisation, routine and specialised in-vitro release testing. The facility staff has extensive industry experience to help clients from emerging and regulated markets in data interpretation and regulatory filing.
The newly extended FD lab facility shall be focused on niche sterile encompassing nano drug delivery systems (nano-emulsion, micelles, in-situ gels, nano-suspension liposomes, microspheres besides Liquid/ Lyophilized injections etc). In addition the lab shall also take up Ophthalmic, topicals, nasal, oral liquid etc. It is well competent to support new drug applications (NDA), 505b2, ANDA, NCE formulation development program for its clients
Strengthened by existing capabilities the Lab shall provides end-to-end capabilities across the spectrum of product design, intellectual property, preclinical pharmacokinetics, regulatory affairs and technology transfer. Ortiv has also cultivated strong relationships with globally esteemed CMOs enabling it to seamlessly navigate the regulatory submission and product commercialisation
The Lab will also focus on collaborative projects with prestigious research institutes like NIPER, ICT Mumbai to develop innovative medicines to address unmet needs to serve the community.
As part of Sotax Pharma Service, along with associated state of the art Analytical Labs in France and US, Ortiv is poised to set industry standards and elevate pharmaceutical research and testing experiences to new heights.
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