NUVO Consultancy is one stop solution provider for pharmaceutical industry.Regulatory StrategiesDossier Due Diligence and Gap Analysis eCTD Publishing : - eCTD Compilation, QC Review, Technical Validation & Submission Hosting- eCTD Lifecycle Management- Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.- Importing and Cloning of Existing eCTD Applications - US FDA: ANDA Dossiers, API DMF Type-II, Excipient DMF, Packaging DMF, Amendments… Show more NUVO Consultancy is one stop solution provider for pharmaceutical industry.Regulatory StrategiesDossier Due Diligence and Gap Analysis eCTD Publishing : - eCTD Compilation, QC Review, Technical Validation & Submission Hosting- eCTD Lifecycle Management- Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.- Importing and Cloning of Existing eCTD Applications - US FDA: ANDA Dossiers, API DMF Type-II, Excipient DMF, Packaging DMF, Amendments, Annual updates, query responses etc…- EU: Dossiers, ASMF, CEP, Query responses, Renewals, variations etc…- GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc…- Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW: Dossiers, DMF, Query responses, Renewals, variations etc…- Pdf publishing: PDF - Ready for Submission, Bookmarking, Hyperlinking, OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory RequirementsUSFDA submissions :Dossier writing, review and filing of ANDA to US FDAUS FDA submission via online portal ESGSPL preparation for US FDAUS listing agent services: - Establishment registration (ER)- Labelor code - NDC & Drug listing - Annual update for ER- Annual Listing Certification for eDRLS- GDUFA cover Sheet filingEU submissions :Dossier writing, review and filing for EU-MAA for MRP, DCP, National fillings.Running the MRP and DCP procedure until approval.MAA submission via online portal CESPSlot applications with health agencies for submissions.CTD Clinical and non clinical modules 2.4, 2.5, 2.6 and 2.7 report writing for EU submission.ROW Submissions:Dossier conversion form National format to CTD, Country specific formats, CTD, ASEAN CTDDMF Submissions: Type –II DMF, ASMF, CEP, Open & Close part, WHO DMF, Type –III and Type –IV US DMF for excipients and packaging materialOnline Electronic Submission Gateways :- Europe – CESP - USA FDA – ESG Indian DCGI Submission : Generics and BiologicsLife-cycle management Show less

Consulting for the Pharmaceutical needs specialized in Regulatory, product development and PV along with all other requirements to invade in global markets like US, Europe, Canada, Australia. MENA, CIS, Latin America including all other markets.Product Development for formulations and APIA dedicated team of people are working in allaince with us for the development of API and formulation.-Formulation development based on QbD-Doing research on implementaion of KASA… Show more Consulting for the Pharmaceutical needs specialized in Regulatory, product development and PV along with all other requirements to invade in global markets like US, Europe, Canada, Australia. MENA, CIS, Latin America including all other markets.Product Development for formulations and APIA dedicated team of people are working in allaince with us for the development of API and formulation.-Formulation development based on QbD-Doing research on implementaion of KASA (Knowledge-Aided Assessment and Structured Application)-lab and Pilot batches-Stability study-Exhibit batches support-Support with any formulation development issuesRegulatory Services :-Regulatory Strategies-Dossier Due Diligence-Dossier Gap Analysis-CTD Module Writing-eCTD Publishing :-USFDA ANDA preparations and submission-US listing agent services:-EU submissions :-CTD Clinical and non clinical modules 2.4, 2.5, 2.6 and 2.7 report writing for EU submission.-ROW Submissions:-DMF Submissions:-Online Electronic Submission Gateways :- Europe – CESP- USA FDA – ESG-Indian DCGI Submission : Generics and Biologics-Life-cycle management : Renewals, Annual reports, Annual updates, variation filing, Amendments …GMP AuditsTraining- Technical Trainings : Regulatory and Quality- Corporate Trainings : Customer service, Communication , Presentation , Negotiation and Business writing skills, Business etiquettesPharmacovigilanceOther extended Support in Value chain:- Sourcing of reference standards- Clinical and BE study- Readability study for EU- Batch release/testing support for EU- Translations- Business development- Turnkey projects Show less

Consulting for the Pharmaceutical needs specialized in Regulatory, product development and PV along with all other requirements to invade in global markets like US, Europe, Canada, Australia. MENA, CIS, Latin America including all other markets.Regulatory Services :-Regulatory Strategies-Dossier Due Diligence-Dossier Gap Analysis-CTD Module Writing-eCTD Publishing : -USFDA ANDA preparations and submission -US listing agent services: -EU submissions… Show more Consulting for the Pharmaceutical needs specialized in Regulatory, product development and PV along with all other requirements to invade in global markets like US, Europe, Canada, Australia. MENA, CIS, Latin America including all other markets.Regulatory Services :-Regulatory Strategies-Dossier Due Diligence-Dossier Gap Analysis-CTD Module Writing-eCTD Publishing : -USFDA ANDA preparations and submission -US listing agent services: -EU submissions :-CTD Clinical and non clinical modules 2.4, 2.5, 2.6 and 2.7 report writing for EU submission.-ROW Submissions:-DMF Submissions:-Online Electronic Submission Gateways : - Europe – CESP - USA FDA – ESG -Indian DCGI Submission : Generics and Biologics-Life-cycle management : Renewals, Annual reports, Annual updates, variation filing, Amendments …GMP Audits Training - Technical Trainings : Regulatory and Quality - Corporate Trainings : Customer service, Communication , Presentation , Negotiation and Business writing skills, Business etiquettes Pharmacovigilance Other extended Support in Value chain: - Product Development- Sourcing of reference standards- Clinical and BE study- Readability study for EU - Batch release/testing support for EU - Translations- Business development - Turnkey projects Show less

We are a leading global services organization that helps clients expedite time-to-market through our services. I manage the technical team and all the projects with customer relationship management.My responsibilities inlude following ; Lead and manage Indian regulatory project teams.  Development and implementation of quality assurance system for all projects. Projects delivery on time with expected quality. Provide global regulatory input to project teams and Business… Show more We are a leading global services organization that helps clients expedite time-to-market through our services. I manage the technical team and all the projects with customer relationship management.My responsibilities inlude following ; Lead and manage Indian regulatory project teams.  Development and implementation of quality assurance system for all projects. Projects delivery on time with expected quality. Provide global regulatory input to project teams and Business development  Interaction with health agencies for faster approval. Ensure that Client’s submissions comply with relevant US/EU/ROW guidelines and update with critical analysis of the risks and issues together with suggested solution. Defining submission strategy, options for scientific advice and creating briefing packages.  Meeting new and existing clients for further business prospects and relationship management.  Define EU filing strategy (CP, MRP, and DCP) identifying risks and issues for various clients. Ensure effective implementation of submission plan, publishing, information and data delivery and archiving of documents across Indian teams. Keep abreast of all the update in legislative and regulatory mandates and ensure that all activities are in compliance with these requirements. Act as key point of contact between Indian team and project managers in Europe. Set objectives and evaluating teams performance on a regular basis.  Responsible for long-term improvement of team’s skills by imparting the necessary training to them. Actively promote concepts of performance improvement, service excellence within the Team. Show less

Managing a team for US, Europe, ROW and Domestic submissions for API and formulation with following key responsibilities: Developing a team for regulated market submissions  Managing eCTD DMF filings for EU, US and ROW markets for Oncology API’s using Pharmaready software. Managing the amendments and annual update electronically as per schedule for DMF for USFDA. Strategy building for regulatory filings and educating other departments for the regulatory requirements.… Show more Managing a team for US, Europe, ROW and Domestic submissions for API and formulation with following key responsibilities: Developing a team for regulated market submissions  Managing eCTD DMF filings for EU, US and ROW markets for Oncology API’s using Pharmaready software. Managing the amendments and annual update electronically as per schedule for DMF for USFDA. Strategy building for regulatory filings and educating other departments for the regulatory requirements. Registration of company with US FDA through SPL using Pharmaready software via ESG. Interaction with various EU Health agencies for booking the slot for oncology formulation application via DCP DCGI submissions for license application for the new facility for oncology formulations. Responsible for regulatory support for all the customer and health agency audits. Provide training sessions at Reliance life sciences institute. Show less

Managing a team for Europe with following responsibilities:• Strategy Building with Marketing and project management.• Efficient Interaction with health authorities for smooth filing. • Well versed with regulatory filing requirements for all the countries over EU.• Managing the Dossier preparation for National filing, mutual recognition procedure (MRP) and decentralized procedure (DCP) for Europe in eCTD and Nees format.• Variation filing via national and MRP for all the… Show more Managing a team for Europe with following responsibilities:• Strategy Building with Marketing and project management.• Efficient Interaction with health authorities for smooth filing. • Well versed with regulatory filing requirements for all the countries over EU.• Managing the Dossier preparation for National filing, mutual recognition procedure (MRP) and decentralized procedure (DCP) for Europe in eCTD and Nees format.• Variation filing via national and MRP for all the registered products in eCTD and Nees format.• Complete lifecycle management of the product registration.• Onsite European submissions via DCP at Ireland.• Good knowledge of the data-base and website of almost all the agencies • Registered with Eudralink and MHRA Portal for communication and submissions.• Involved in strategy building for EU and booking slots for DCP and MRP.• Training subordinates to excel in their work.• Scientific advice guidance to the development team.• Part of team for monitoring the complete activity for from development of product to placing the product in the market  Expert with ANDA submissions Expert with DMF filing with US FDA and European agencies, Canada and ROW. Expert with CEP application with EDQM. Have in depth understanding of API development process starting from R&D, scale up, technology transfer, and final plant production and validation of the API process.  Queries: Quick solving of all the queries on drug substance and drug product received from worldwide health authorities for DMF, ANDA, MRP, DCP etc  Involved in API strategy and Building of API score card for the company. Well versed with ICH guidelines for Quality and CTD documents. Show less

 Preparation of registration documents (Dossiers) for Formulations as per requested countries guidelines for South East Asia, Latin America and European countries  Preparation of Legal documents like Certificate of pharmaceutical product, Free Sale certificate. Preparation of Kota documents and re-registration and renewal dossiers for South East Asia, Latin America and European countries

 Preparation of Dossiers for Formulations as per respective countries guidelines for Central American countries : Mexico, Colombia, Ecuador, Guyana, Bolivia, Chile, Guatemala, Gabon etc., Turkey, Zimbabwe, France and South African countries. Preparation of Legal documents like Certificate of pharmaceutical product, Free Sale certificate. Handling of tender process

MR at Main Cardiac division  Area of action was Santacruz and Vile Parle (India). Meeting doctors and making them understand of company’s pharmaceutical product. Handling C & F and sales.