Simpex Admin

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<p><strong>Simpex pharma Pvt. Ltd.</strong> 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.</p>

<p>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.</p>

<p>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.</p>

<p>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.</p>

<p>This PSMF provides a description of the PV system for the medicinal 
products as per pharmacovigilance norms and requirements form various 
regulatory bodies.</p>

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