Shalaka Thakre's Contact Details

Shalaka Thakre's Company Details

Metina PharmConsulting Pvt. Ltd

, Maharashtra, India • 11 - 50 Employees
Pharmaceuticals

Metina is a Regulatory Affairs consulting firm having expertise in submissions and approvals for USA, EU and Emerging Markets and expertise in filing & approval of ANDA, NDA, NCE as well as Branded Generic Products across the globe. Metina currently offers consultancy services to Pharmaceutical Industry and covers end to end regulatory and business development activity covering strategy development, due diligence of dossier, in -license/out-license of dossiers, Submission Management to Health Authorities, GMP audits Personal meeting with Health Authorities and product market launch.\\Why Metina: \\USA - direct submission to FDA through ESG\EU - Regulatory Strategy and submission through DCP, MRP or National Route across EU Member states, MA holder & EUQP PV.\End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, GMP/GCP Inspection support, Exigencies response, Pricing approval, Marketing Authorization Approval & Product Life Cycle Management\Across the globe regulatory support i.e. USA, EU, ASEANs, GCC, MENA, AFRICA, BRAZIL, JAPAN, South Africa, Australia and New Zealand, Taiwan, Indonesia & India\Expertise in DMF, ASMF, IMPD, CTA, NDA, ANDA, MAA, Branded Generic Application & FDC submission\Dossiers in US-CTD, EU-CTD, GCC-CTD, ASEAN-CTD, Brazil -CTD, India-CTD, SA-CTD, Australia-CTD, Kenya & Uganda CTD, Tanzania CTD\Manage various dosage forms - Oral Solids, Oral Liquids, Topicals, Nasal Sprays, Inhalation Products, Injectables, Medical Patches