Our Regulatory Process
A structured 7-stage regulatory methodology covering everything from initial consultation and dossier preparation to submission, query resolution, and continuous post-approval compliance monitoring.
Our 7-Stage Regulatory Methodology
At MedRegX India, regulatory consulting is not a one-size-fits-all service. Every product, every business, and every regulatory body operates under distinct technical and procedural requirements. Our proprietary 7-stage regulatory methodology was developed over years of direct experience with CDSCO, FSSAI, BIS, AYUSH licensing authorities, State Pollution Control Boards, and international certification bodies.
The methodology is designed to eliminate ambiguity at every stage of the regulatory process. Before we file a single application, we have already identified every document requirement, anticipated every probable query, pre-audited every technical data point, and built a submission timeline that aligns with your business launch targets. This front-loaded approach — investing heavily in preparation before submission — is the primary reason for our 98% first-submission approval rate across more than 500 licensing engagements.
Our process applies across all regulatory domains: medical device registration and import licensing under MDR 2017, pharmaceutical drug license applications under the Drugs and Cosmetics Act 1940, cosmetic registration under the Cosmetics Rules 2020, FSSAI food and nutraceutical licensing under the FSS Act 2006, AYUSH manufacturing licenses under Schedule T, EPR registrations under CPCB rules, and BIS CRS and FMCS certifications under Quality Control Orders.
Initial Consultation & Scope Assessment
Every engagement begins with a free 30-minute discovery call. Our senior regulatory consultants evaluate your product category, intended market, and business timeline. We identify the applicable regulatory authority — whether CDSCO, FSSAI, BIS, AYUSH, or State PCBs — and define the precise licensing pathway. This prevents misdirected applications and saves weeks of rework.
- Product classification under MDR 2017, Drugs Act, Cosmetics Rules 2020, or FSS Act 2006
- Identification of applicable central and state regulatory bodies
- Preliminary timeline and fee estimation with zero hidden costs
- Assessment of existing certifications (CE, ISO 13485, FDA) for fast-tracking
Regulatory Gap Analysis & Compliance Roadmap
Our regulatory experts conduct a thorough gap analysis against all applicable standards — Schedule M for pharma, MDR 2017 for devices, Schedule T for AYUSH, and IS standards for BIS. We deliver a written compliance roadmap identifying every document, test report, certificate, and inspection requirement before a single application is filed.
- GMP gap assessment against Schedule M, WHO-GMP, and ISO 13485:2016 requirements
- Technical documentation audit for CE marking dossiers and CTD/eCTD formats
- Identification of mandatory lab tests: biocompatibility (ISO 10993), stability (ICH Q1), heavy metals
- Written action plan with prioritized tasks, dependencies, and milestone deadlines
Documentation Preparation & Dossier Compilation
Documentation quality is the single most important factor in approval success. Our team prepares all technical dossiers, QMS manuals, SOPs, Master Files, and application forms to the exact specifications of the regulatory authority. For medical devices, we compile Device Master Files and Plant Master Files per GHTF guidelines. For pharmaceuticals, we prepare Site Master Files and CTD modules.
- Device Master File (DMF) and Plant Master File (PMF) compilation per GHTF/IMDRF guidelines
- ISO 13485 Quality Management System documentation and implementation support
- Common Technical Document (CTD) modules for New Drug Applications and IND filings
- Formulation cards, stability data summaries, and analytical method validations per ICH Q2R1
Regulatory Submission & Authority Liaison
With the dossier pre-audited and complete, our team files applications directly on SUGAM, FoSCoS, BIS portals, and SPCB systems. We manage all government fee payments, tracking IDs, and portal statuses. Our direct liaison with CDSCO Drug Inspectors, FSSAI Food Safety Officers, and BIS Field Inspectors ensures no communication gap between the authority and your business.
- End-to-end portal submission management on SUGAM, CDSCO online, FoSCoS, and BIS CRS portals
- Direct liaison with CDSCO Zonal offices, FSSAI regional offices, and State Drug Controller offices
- Coordination of mandatory site inspections (GMP audits, FSSAI premises inspections, BIS factory visits)
- Real-time status tracking and client progress reports at every regulatory milestone
Query Resolution & Deficiency Management
Regulatory authorities routinely raise technical queries and deficiency letters. Our team responds to all queries within 72 hours with technically accurate, authority-compliant answers. We handle CDSCO SUGAM query uploads, FSSAI clarification submissions, BIS testing coordination, and SPCB additional information requests — preventing approval delays caused by slow or incomplete responses.
- CDSCO deficiency letter analysis and point-by-point technical response preparation
- Coordination of additional lab tests, revised test reports, and supplementary clinical data
- BIS portal query management and re-test coordination with BIS-recognized laboratories
- FSSAI scientific panel clarification submissions for non-standard food formulations
License Delivery, Handover & Post-Approval Support
Upon approval, we deliver a complete compliance handover package including the original license, all supporting documentation, and a post-approval compliance calendar. We brief your internal teams on license conditions, mandatory reporting obligations, adverse event reporting requirements, and annual return deadlines. The approval is not the end — ongoing compliance is where real regulatory risk lies.
- Delivery of original licenses, registration certificates, and certified true copies for import customs
- Post-approval compliance briefing covering license conditions and regulatory obligations
- Mandatory adverse event reporting setup for CDSCO medical device vigilance program
- FSSAI annual return filing support and periodic compliance audits
Renewal Management & Continuous Compliance Monitoring
Regulatory licenses have expiry dates, and lapses can shut down operations immediately. MedRegX proactively tracks all license renewal deadlines — typically 3 months in advance — and manages the renewal applications without disrupting your operations. We also monitor regulatory changes from CDSCO, FSSAI, BIS, MoEFCC, and other bodies, alerting clients to compliance changes that affect their products.
- Proactive license renewal tracking and renewal application management 90 days before expiry
- Monthly regulatory change alerts covering CDSCO notifications, FSSAI amendments, and BIS revisions
- Annual GMP compliance review and mock audit preparation for license renewals
- Continuous post-market surveillance support and CDSCO Medical Device Information System updates
Why This Process Delivers Results
The single most common reason regulatory applications fail in India is incomplete or non-conforming documentation. CDSCO alone issues deficiency letters for over 60% of first-time medical device submissions from applicants who file without professional regulatory support. FSSAI applications without pre-vetted formulation data routinely face 6–12 month delays. Our front-loaded documentation methodology ensures that by the time we file, every technical requirement has been double-checked by at least two regulatory experts.
Our direct relationships with regulatory authorities — including CDSCO SUGAM helpdesk officers, FSSAI regional offices, BIS field inspectors, and State Drug Controller offices across India — give our clients a distinct advantage in query resolution timelines. When a deficiency letter is issued, our ability to engage directly with the reviewing authority reduces resolution time from the industry average of 45 days to under 15 days in most cases.
For foreign manufacturers, our role as Authorized Indian Representative (AIR) eliminates the need for dedicated regulatory staff in India. We assume full statutory responsibility for all CDSCO liaison activities, import license management, adverse event reporting, and post-market surveillance obligations — allowing international companies to enter the Indian market without establishing a local regulatory infrastructure.
Ready to Start Your Regulatory Journey?
Our team is ready to begin your compliance engagement with a free 30-minute consultation. No obligation, no fee.
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