In line with the expansion of its regulatory consultancy, Rephine has appointed Bhavik Joshi as Assistant General Manager for Regulatory Affairs.
Bhavik has gathered more than 12 years of Global Regulatory Affairs experience in different pharmaceutical Industries which either are dealing with generic products or in innovator product segment. His regulatory experience covers initial Marketing Authorisation Application (MAA) and Product Life-cycle Management (LCM) for different countries like Europe, US, Canada and RoW market. Bhavik holds Master’s Degree in Pharmaceutics.
Along with Regulatory Affairs expertise, he also holds experience in regulatory project management, Pharmacovigilance, Regulatory business development and its continuity. Bhavik has successfully coordinated multiple number of regulatory and pharmacovigilance projects as individual or along with his team where he was actively involved in finalising regulatory strategy roadmap, technical review of core documents, drafting of CTD dossier, eCTD compilation, query response drafting, variation package preparation and submission management to authority.
Bhavik is working as Assistant General Manager at Rephine where he takes care of regulatory submission management of dossier, regulatory service expansion and product life cycle management activities globally.
Bhavik is based in India, where Rephine has recently established a legal entity, “Rephine Consulting India Private Limited”, with offices in Delhi, Hyderabad and Ahmedabad.
“Indian companies wishing to promote their products or services in Europe now have an easy channel through Rephine who can offer a complete end-to-end service for both European and UK registrations including support in all quality and regulatory compliance matters,” said Rephine’s CEO, Rino Coladangelo.
Rephine can provide a complete portfolio of regulatory services to the pharmaceutical industry worldwide, from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, full marketing authorisation (MA) support, eCTD dossier preparation and regulatory strategy consultation specific to the clients’ needs.
Clients can contact Rephine at enquiries@rephine.com to require further information.