Regovex Consulting Aligarh

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Business Category : Regovex Consulting Uttar Pradesh India

21
Consulting

Profile / Products /Services :

# Regovex Consulting - Leading Regulatory & Licensing Consultants in India ## About Regovex Consulting Regovex Consulting is a premier regulatory affairs and licensing consultancy firm based in India, dedicated to helping healthcare, pharmaceutical, food, cosmetic, and medical device enterprises navigate complex statutory compliance landscapes. Establishing and operating a business in regulated sectors requires strict adherence to local, state, and central government frameworks. Regovex Consulting bridges the gap between regulatory requirements and commercial deployment by delivering end-to-end advisory, document dossier compilation, and licensing acquisition services. Headquartered in Aligarh, Uttar Pradesh, Regovex Consulting supports entrepreneurs, small and medium enterprises (SMEs), multinational corporations, contract manufacturers, and importers across India. Our team combines deep technical knowledge of statutory provisions with practical experience in dealing with licensing authorities, ensuring seamless approvals, minimal compliance risk, and fast-track market entry. --- ## Core Regulatory Services & Capabilities ### 1. FSSAI Food Safety Licensing and Registration Food safety compliance is mandatory for any enterprise involved in the manufacturing, processing, packaging, storage, distribution, or import of food products in India. Regovex Consulting provides structured assistance across all tiers of the Food Safety and Standards Authority of India (FSSAI) regulatory framework: - Basic FSSAI Registration: Tailored for micro-vendors, petty manufacturers, and small food businesses operating under prescribed turnover thresholds. - State FSSAI License: Designed for mid-sized food processing units, regional distributors, storage facilities, and food service establishments. - Central FSSAI License: Required for large-scale food manufacturers, 100% export-oriented units (EOUs), importers, e-commerce food platforms, and multi-state operations. - FSSAI License Renewal & Modifications: Timely renewal filings on the FoSCoS portal to prevent operational disruption, penalty charges, or license cancellations. ### 2. CDSCO Medical Device & In-Vitro Diagnostic (IVD) Approvals Under the Medical Devices Rules (MDR), manufacturing or importing medical devices and IVD equipment into India requires registration with the Central Drugs Standard Control Organization (CDSCO). Regovex Consulting supports device manufacturers and importers with: - Device Master File (DMF) and Site Master File (SMF) compilation in alignment with statutory standards. - Registration for Class A, B, C, and D medical devices. - IVD performance evaluation reports and laboratory testing clearance coordination. - Form MD-42 registration for stockists, wholesalers, and retail distributors of medical devices. ### 3. Pharmaceutical & Drug Licensing Operating a wholesale or retail drug enterprise in India necessitates approval from State Drug Control Authorities under the provisions of the Drugs and Cosmetics Act. Regovex Consulting offers guidance for: - Form 20B and Form 21B wholesale drug licenses for non-biological and biological pharmaceuticals. - Retail pharmacy and medical store licensing, including premise layout audit readiness and registered pharmacist verification. - Manufacturing license applications and compliance reviews according to Schedule M standards. ### 4. Cosmetic Licensing & Contract Manufacturing Setup The cosmetics market in India is governed strictly to protect consumer safety. Regovex Consulting assists domestic brand owners and overseas cosmetics manufacturers with: - Form COS-2 cosmetic import registration for international brands entering the Indian market. - Cosmetic manufacturing licenses under Form 32. - Cosmetic loan licensing (Form 31-A) for virtual brands utilizing third-party contract manufacturing infrastructure. - Ingredient safety verification and packaging label audit against Indian Standard (IS) benchmarks. ### 5. Pharmacovigilance & Periodic Safety Update Reports (PSUR) Post-market safety monitoring is essential to retain market authorization for pharmaceutical products and medical devices. Regovex Consulting provides specialized pharmacovigilance services, including: - Periodic Safety Update Report (PSUR) drafting, signal evaluation, and risk-benefit analysis. - Post-marketing surveillance dossier compilation for submission to CDSCO. - Advisory support on maintaining global and domestic safety databases. --- ## Why Partner with Regovex Consulting? - End-to-End Dossier Preparation: We handle complex technical documentation, verification of layout specifications, and administrative paperwork to present defect-free applications. - Proactive Risk Mitigation: By auditing compliance documentation prior to submission, we prevent application rejections, query loops, and avoidable approval delays. - Industry Expertise: Our team maintains up-to-date knowledge of evolving regulatory policies, notifications, and portal updates issued by FSSAI, CDSCO, and State FDA departments. - Transparent & Efficient Workflows: We offer structured advisory roadmaps, clear timelines, and constant updates throughout the licensing lifecycle. --- ## Contact Information - Business Name: Regovex Consulting - Primary Website: https://www.regovexconsulting.com - Location: Aligarh, Uttar Pradesh, India - Phone: +91 90847 06423 - Email: info@regovexconsulting.com