The Indian pharmaceuticals sector is a rapidly emerging global hub - thanks to the well-established domestic manufacturing base and skilled workforce. With 60% of the world's immunizations and 20% of the non-exclusive prescriptions manufactured here, it has earned the moniker of ‘the pharma store of the World'. Despite limited research resources, supply chain disruptions, and poor infrastructure, new segments such as medical tourism, biopharma, clinical trials, and pharma packaging contribute to the industry's growth trajectory.
Zenvision Pharma (www.zenvisionpharma.com) is a pharmaceutical contract research and development organization that spans over 20,000 sq. ft of area with dedicated departments that support the requirements of business partners and regulators to meet the global formulation development standards. Their team of intellectual property specialists, formulation scientists, analysts, regulatory and quality assurance professionals, and project management professionals ensure that every formulation development project is fully supported - from concept to commercialization.
Image Courtesy: www.zenvisionpharma.com
In 2015, Zenvision Pharma was founded by Dr B. V. Sivakumar and Mr Sunil. H. Pophale. Sunil Pophale holds a B.Tech from IIT Bombay and has over 28 years of experience in brand building. He is the founder of Fem Care Pharma and Ree Laboratories. Dr B.V. Sivakumar has a PhD in organic chemistry and has over 25 years of experience in R&D. He has published over 25 scientific papers in reputed international journals and has filed over 100 patent applications.
For the highly regulated markets (USA, Europe) and the semi-regulated markets (EU, S Africa), Zenvision offers professional product development services (compliant with ICH Q8, ICH Q9, ICH Q10) for generics and speciality pharmaceuticals. They provide analytical method development and validation; stability studies and analysis for commercialization; and clinical study design, monitoring, and technical support. In addition to providing process development (synthetic research), quality assurance and compliance solutions, it also offers regulatory services such as Dossier Review, eCTD filing, gap analysis and documentation of CTD and ACTD dossiers.
In Zenvision Pharma, formulation development is based on QbD (Quality-By-Design)/DoE (Design of Experiments) principles stipulated by USFDA/EMEA. Quality Target Profiles (QTP). The product development phase undergoes rigorous Critical Quality Attributes (CQA) checks and risk assessment. With a full-fledged R&D centre covering four floors plus a basement for formulations, analytical laboratories, stability chambers and offices, Zenvision Pharma has filed 28 patents/PCTs.
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