Simpex pharma Pvt. Ltd. specializes in manufacturing of pharmaceutical products. Simpex started its operation as an Export House. With its focused approach in Pharmaceutical Market and quest for constant research and development, Simpex today has evolved itself as an organization having manufacturing plant, which complies with the maximum norms set by World Regulatory Boards. Simpex has well established operations in Countries like Russia, Ukraine, Kazakhstan, Belarus, Uzbekistan, French African Countries, ASEAN, Sri Lanka, India etc.
Simpex has its distribution and marketing agreement with Global Exim FZC for the promotion and distribution of its products in the territories like U.A.E., Russia and other CIS countries.
Simpex has decided to outsource pharmacovigilance activities and has delegated the set-up and maintenance of the global and local PV system to a service provider-PharmaLex India Pvt. Ltd. (PharmaLex). PharmaLex also provides Simpex with compilation and maintenance of the Pharmacovigilance System Master File (PSMF). Pharmacovigilance activities will be carried out at PharmaLex office in New Delhi, India. All communication (e.g. correspondence, safety data and document exchange) between service providers and Simpex will be in English language.
Marketing Authorization Holder (MAH) and Qualified Person Responsible for Pharmacovigilance (QPPV) ensure PharmaLex is provided with current and valid information needed for performing of PV activities and meeting regulatory timelines and requirements as PharmaLex’ operational site is in India.
This PSMF provides a description of the PV system for the medicinal products as per pharmacovigilance norms and requirements form various regulatory bodies.