Viveekk Singh, Founder And Ceo Tacit Medtek. M. Tech (Quality), M. Pharm (Regulatory Affairs) Email & Phone Number

Delhi, India

Mumbai, Maharashtra, India

Medical Device consulting for Regulatory Affairs and Quality Management System.

Ahmedabad, Gujarat, India

• Preparation of techno-commercial strategy for international market entry. • Compilation and review of Regulatory Dossiers in country specific formats for timely submissions for Regulated and Semi-regulated markets including EU / India / LATAM / CIS / ASEAN / African / GCC countries.• Strategic lead from company to coordinate and set up foreign subsidiaries of the company.• Travelling to foreign countries, if required, to resolve the issues related to products registration and… Show more • Preparation of techno-commercial strategy for international market entry. • Compilation and review of Regulatory Dossiers in country specific formats for timely submissions for Regulated and Semi-regulated markets including EU / India / LATAM / CIS / ASEAN / African / GCC countries.• Strategic lead from company to coordinate and set up foreign subsidiaries of the company.• Travelling to foreign countries, if required, to resolve the issues related to products registration and procurement of licenses for local product commercialization. • Responsible for Re-registration and Registration of medical device with CDSCO (India). • Acting as a regulatory expert in cross functional teams including R&D, Project Management, Marketing, Clinical, QA and Production to ensure regulatory compliance. • Part of Product Development Team to ensure regulatory compliance from product R&D to commercialization. Performing regulatory research and providing regulatory support for new products in development stages.• Interface and coordinate with regulatory agencies/competent authorities on submissions, approvals, queries, audits etc. • Compliance check for Packaging / Labeling / Promotional Material.• Coordination with various departments to collect submission documents. • Review and approve various technical documents. • Conduct training to cross functional teams on regulatory requirements across world.• Communicating with Global Marketing counterparts for dossier registration and to resolve the issues. Show less

Vadodara Area, India

• Global regulatory submission in country specific formats in timely manner for Regulated and Semi-regulated markets including EU, India with neighboring countries, LATAM / CIS / ASEAN / African / GCC countries.• Preparation of Technical File / design Dossier for CE marking of orthopedic implants (Including products from Class IIa, Class IIb and Class III) and instruments. • Handling Audits from ISO Auditors / Notified Bodies / Local FDA officials. • Act as Regulatory lead in… Show more • Global regulatory submission in country specific formats in timely manner for Regulated and Semi-regulated markets including EU, India with neighboring countries, LATAM / CIS / ASEAN / African / GCC countries.• Preparation of Technical File / design Dossier for CE marking of orthopedic implants (Including products from Class IIa, Class IIb and Class III) and instruments. • Handling Audits from ISO Auditors / Notified Bodies / Local FDA officials. • Act as Regulatory lead in strategizing, preparation and submission of all kinds of regulatory documents and other communications to government bodies and notified body.• Preparation of various reports including Design Verification and Validation Reports, Non Clinical and Clinical Evaluation Reports, Risk Management Report.• Review of technical documents such as Risk Management Report, Essential Safety Requirements, Packaging Validation, Sterilization Validation, Engineering Drawings, Process validation protocol and report, Raw Material and Finished Products specification, analytical method validation protocol and report and stability reports for compliance with regulatory requirements.• Co-ordination with country regulatory counterparts for regulatory compliance during and after approval.• Preparation of documents for New Products Permission, Free Sale Certificate etc.• Ensure the appropriate licensing, and legal compliance of the product.• Search of consultants, review of contracts, negotiation and finalization of consultants for registration in various countries. • Coordinating with various testing labs to communicate requirements, finalize contract, ensuring timely completion of test and receipt of final reports. Additional Responsibilities:• Involved in the new plant layout design, facility specification decision, preparation and finalization of man and material flow etc. • Involved in new quality system development for smooth production from raw material receipt to final dispatch. Show less

Vadodara Area, India

• Preparation of techno-commercial strategy for international market entry, • Medical Devices Registration/re-registration/post approval changes, • CE Marking - Technical file / Design Dossier preparation,• CDSCO & local FDA submissions, • Audit handling, • Training, • Preparation of Design/Risk/Clinical documentation.

New Delhi Area, India

• Preparation of dossiers for Import registration and import license for Medical Devices, Pharmaceuticals and Procedure Packs in India.• Preparation of dossier for Pharmaceuticals (CTD & in country specific format) and medical devices for semi regulated markets.• Preparation of documentation for Global Clinical Trial approvals for Medical Devices and Pharmaceuticals in India.• Preparation of documentation for Critical and Non-Critical In-Vitro Diagnostics (IVD) for import into… Show more • Preparation of dossiers for Import registration and import license for Medical Devices, Pharmaceuticals and Procedure Packs in India.• Preparation of dossier for Pharmaceuticals (CTD & in country specific format) and medical devices for semi regulated markets.• Preparation of documentation for Global Clinical Trial approvals for Medical Devices and Pharmaceuticals in India.• Preparation of documentation for Critical and Non-Critical In-Vitro Diagnostics (IVD) for import into India. • Submission, follow up, technical discussion with CDSCO officials on assigned projects and updating the status to customers. • Preparation and delivery of Technical Presentation (PPT) to CDSCO officials in response to query letter raised on the product registration. • Respond to the queries of various divisions of CDSCO including New Drug Division, Import Division, Medical Devices and Diagnostics Division, Clinical Trial Division.• Act as regulatory contact from company to coordinate with various customers on assigned projects to communicate regulatory requirements, review of documents, perform GAP analysis, inform deficiencies, discussion of submission strategy, prepare and inform anticipated queries and update the registration status. • Coordination and follow up with customers to ensure complete and timely submission. • Highlight the regulatory issues that can be there and to resolve them.• Ensure the documents are error free and have minimum deficiencies.• Ensure the appropriate licensing, and legal compliance of the product. Show less

New Delhi Area, India

• Planning, preparation, submission and follow up of dossiers for Drugs / Medical Devices products for registration with CDSCO. • Import Registration of Drugs and Medical Devices.• Clinical Trial Approval for Drugs and Medical Devices. • Responding to queries of Regulatory Authorities.• In-Vitro Diagnostics (IVD) - Registration and Import License Application.

Master Of Technology - Mtech, Quality Management, Cgpa - 8.96

M.Pharm (Drug Regulatory Affairs And Pharmaceutical Management), Regulatory Affairs, Pharmaceutical Manegement, Import-Export And International Business Management

B.Pharma, Jurisprudence,Pharmceutics,Pharmacology, Pharmaceutical Chemistry,Pharmacognosy,Physical Chemistry,