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
• 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).

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
• 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.

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,

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 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.

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,