Deepak Sohoni Email & Phone Number

Global Headquarter, Wockhardt Tower, Bandra Kurla Complex, Mumbai - 400051

Setting up calendar for re-registration submission plans.Coordination with Business Heads and VP for Business planning and regulatory submission timelines.Planing for Bio-similar products dossiers and variation filing.Plant inspection and review of technical documents of all contract manufacturing sites for export registration.Implementation of artwork.

Successfully completed 12 clinical trials with registration at CTRI site.Key Accomplishments:* Discussing with various doctors and investigators for finalization of Clinical trial protocol, CaseRecord Form and other source documents.* Conducting Site Feasibility visits, Pre-trial visits, interim monitoring visits and study close outvisits as per schedule Y.

* Presentation to state and central regulatory authority for new drug development and replying theirqueries; Regulatory AffairsResults: Life cycle management of registered products and domestic registrations of new products.Key Accomplishments:* Application to CDSCO for manufacturing site registration, manufacturing and marketing of newdrug formulation.

Drug Regulatory Affairs.Results: Successfully achieved the target of setting up of in-house computer system for datamanagement.Key Accomplishments:* Setting up of Document Management System in coordination with IT, formulation development,Analytical Development, QC, PPIC, Packaging and manufacturing plant.* Updation of Site Master files for Paithan plant.

Exports Registration.Key Accomplishments:* Dossier preparation and regulatory submissions for Africa, CIS for its viral, bacterial andrecombinant vaccines* Company registrations in various countries to initiate trade with those countries.* Co ordination of cGMP audits. Pre and post audit submissions

Co-ordination with other departments for technical inputs.* Evaluation of the documents received from support departments.* Data management in single domain to avoid repeatability and access to recent updates; Phytochemistry & Drug Regulatory Affairs.Key Accomplishments:* Compilation of registration dossiers for solid and liquid oral dosage forms.

Standardization of herbal raw material, with macroscopical & microscopical examination.* Study of Physico-chemical parameters (Identity, Purity & Strength tests) of herbal raw material,as per Ayurvedic Indian Pharmacopoeia.* Phyto-chemical and HPTLC analysis of herbal raw materials, extracts and their products, basedon marker compounds like alkaloids.

Education record

M.Sc; Ph.D, Botany