What We Do
Regulatory Licensing Services
Comprehensive licensing support for drug, cosmetics, and food supplement manufacturers — backed by 15+ years of regulatory expertise.
Pharmaceuticals
Drug Manufacturing Licenses
CDSCO · State FDA · Schedule M · Revised GMP Compliance
IMEX Consultancy Services provides end-to-end support for pharmaceutical manufacturing units to ensure compliance with the Drugs & Cosmetics Act, 1940, Rules 1945, GMP standards, and Revised Schedule M guidelines. Our expert team assists pharmaceutical entrepreneurs, startups, existing manufacturers, and marketers in establishing, operating, and expanding their manufacturing facilities.
- Preparation and submission of manufacturing license applications
- Guidance for setting up GMP-compliant pharmaceutical facilities
- Plant layout design and facility planning per Schedule M requirements
- Documentation: SOPs, BMRs, BPRs, Specifications & Validation Protocols
- Revised Schedule M compliance and gap analysis
- GMP audits, mock inspections and audit response support
- Technical support for Tablets, Capsules, Liquid Orals, Ointments, Nutraceuticals & Medical Devices
- Site Master File (SMF) and Quality Manual preparation
- Validation & Qualification support (DQ, IQ, OQ, PQ)
- Water system, HVAC and cleanroom qualification guidance
- Product permission and product registration assistance
- Loan license, contract manufacturing & third-party manufacturing arrangements
- Product dossier preparation and technical documentation
- Stability study protocol and documentation support
- GMP, GDP, GLP and regulatory compliance training programs
- Export documentation and regulatory consultancy for international markets
Regulatory Authorities
- CDSCO (Central Drugs Standard Control Organisation)
- State FDA / Drug Control Departments (FDCA)
- Ministry of Health & Family Welfare
Retail & Wholesale
Retail & Wholesale Drug Licenses
Drugs & Cosmetics Act, 1940 · FDCA · CDSCO
IMEX Consultancy Services provides professional consultancy and regulatory assistance for obtaining, renewing, and amending Retail and Wholesale Drug Licenses under the Drugs & Cosmetics Act, 1940 and Rules, 1945. We assist pharmacies, medical stores, distributors, stockists, hospitals, and healthcare organisations in achieving full regulatory compliance.
- New Retail Drug License and Wholesale Drug License applications
- Retail-cum-Wholesale Drug License consultancy
- License renewal, retention and amendment support
- Addition or change of competent person / registered pharmacist
- Change in firm constitution (Proprietorship, Partnership, LLP, Company)
- Change of premises and address amendments
- Addition of drug categories — Schedule C, C(1), H, H1, and X drugs
- Compliance documentation and record maintenance guidance
- Online application preparation and submission
- Regulatory compliance audits and inspection preparedness
- Support for hospital pharmacies and institutional sales licenses
- Guidance on storage conditions, cold chain and documentation
- Liaison and follow-up with licensing authorities
- Compliance support for e-pharmacy and distribution operations
- Assistance in responding to regulatory notices and observations
Regulatory Authorities
- State FDA / FDCA (Food & Drugs Control Administration)
- CDSCO (Central Drugs Standard Control Organisation)
- State Drug Licensing Authorities
Our Expertise Covers
- Retail Medical Stores & Pharmacies
- Wholesale Drug Distributors
- Stockists and Super Stockists
- Hospital Pharmacies
- Surgical and Medical Device Dealers
- Ayurvedic and Homoeopathic Drug Dealers
- Veterinary Drug Dealers
Cosmetics & Personal Care
Cosmetic Manufacturing License & Import Registration
Cosmetics Rules, 2020 · CDSCO · State Licensing Authorities
IMEX Consultancy Services provides comprehensive consultancy and regulatory support for obtaining Cosmetic Manufacturing Licenses and Cosmetic Import Registrations in accordance with the Cosmetics Rules, 2020 and applicable regulations of CDSCO and State Licensing Authorities.
- New Cosmetic Manufacturing License applications
- Factory setup and facility planning per Cosmetics Rules, 2020
- Manufacturing site layouts and technical documentation
- SOPs, specifications and quality control document preparation
- GMP compliance guidance for cosmetic manufacturing facilities
- Product formulation and regulatory review
- Label and artwork compliance verification
- Addition of new cosmetic products and categories
- Amendment, renewal and retention of cosmetic licenses
- Regulatory inspection preparation and support
- Compliance audits and corrective action plans
- Cosmetic Import Registration Certificate applications (CDSCO)
- Regulatory dossier preparation and review for importers
- Labeling and packaging compliance per Indian regulations
- Ingredient review, regulatory assessment and Free Sale Certificates
- Coordination with overseas manufacturers for documentation
- Registration amendments and post-approval compliance support
Regulatory Authorities
- CDSCO (Central Drugs Standard Control Organisation)
- State Drug Licensing Authorities
- Ministry of Health & Family Welfare
Products Covered
- Face Washes and Cleansers
- Creams and Lotions
- Shampoos and Conditioners
- Hair Oils and Hair Serums
- Soaps and Body Washes
- Sunscreens and Skin Care Products
- Baby Care Products
- Cosmetics and Beauty Products
- Personal Hygiene Products
- Herbal and Natural Cosmetics
Medical Devices & IVDs
Medical Device License Services (Class A, B, C & D)
Medical Devices Rules, 2017 · CDSCO · ISO 13485
IMEX Consultancy Services provides complete regulatory consultancy and licensing support for Medical Devices and In-Vitro Diagnostic (IVD) Devices under the Medical Devices Rules, 2017. We assist manufacturers, importers, distributors, and marketers in obtaining approvals and maintaining regulatory compliance with CDSCO and State Licensing Authorities.
- Manufacturing License for Class A, B, C & D Medical Devices
- Import License for Medical Devices and IVDs
- Loan License and Contract Manufacturing support
- Registration and licensing through CDSCO Online Portal
- Product classification and regulatory strategy
- Device Master File (DMF) and Plant Master File (PMF) preparation
- Quality Management System (QMS) implementation per ISO 13485
- Risk Management Documentation per ISO 14971
- Clinical Evaluation and Performance Evaluation guidance
- Labeling and packaging compliance review
- Amendment, endorsement and retention of licenses
- Regulatory audit and inspection readiness
- Post-Market Surveillance and Vigilance compliance
- Authorized Indian Agent services for foreign manufacturers
- Essential Principles Checklist and regulatory submission dossiers
- Stability and validation document preparation
Regulatory Authorities
- CDSCO (Central Drugs Standard Control Organisation)
- State Drug Licensing Authorities
- Bureau of Indian Standards (BIS)
Device Classification Coverage
- Class A — Surgical Dressings, Gloves, Thermometers, Hospital Furniture
- Class B — Hypodermic Needles, Infusion Sets, BP Monitors, Nebulizers
- Class C — Orthopedic Implants, Ventilators, Hemodialysis Equipment
- Class D — Heart Valves, Coronary Stents, Pacemakers, HIV Diagnostic Kits
- In-Vitro Diagnostic (IVD) Devices
- Imported Medical Devices and IVDs
Documentation Support
- Device Master File (DMF)
- Plant Master File (PMF)
- ISO 13485 Documentation
- Quality Manual and SOPs
- Risk Analysis Reports
- Clinical Evaluation Reports
- Essential Principles Checklist
- Stability and Validation Documents
- Product Technical Files
- Regulatory Submission Dossiers
Nutraceuticals & Health
Food Supplement Licenses
FSSAI · Nutraceuticals · Health Supplements
India's nutraceutical and health supplement market is governed by FSSAI under the Food Safety & Standards Act. IMEX manages the complete regulatory pathway — from product classification and formulation review to license acquisition and ongoing compliance.
- FSSAI Central & State license applications
- Nutraceutical and health supplement product approvals
- Novel food ingredient notifications
- Product formulation and labeling compliance
- FSSAI audit preparation and support
- License renewal and compliance monitoring
Regulatory Authorities
- FSSAI (Food Safety and Standards Authority of India)
- Ministry of Health & Family Welfare
- State Food Safety Departments
Testing & Analysis
Drugs & Food Testing Support Services
Government Approved Labs · NABL-Accredited · IP / BP / USP / FSSAI Standards
IMEX Consultancy Services provides comprehensive assistance for testing and analysis of Drugs, Cosmetics, Medical Devices, Food Products, Nutraceuticals, and Health Supplements through Government Approved Public Testing Laboratories and NABL-accredited laboratories. We assist manufacturers, importers, marketers, distributors, and regulatory authorities in obtaining reliable analytical reports and ensuring regulatory compliance.
- Coordination with Government and Public Testing Laboratories
- Drug sample testing per IP, BP, USP and pharmacopoeial standards
- Food testing as per FSSAI requirements and standards
- Cosmetic product testing and analysis
- Medical device and material testing support
- Nutraceutical and health supplement testing
- Raw material testing and verification
- Finished product testing and release support
- Stability testing coordination and shelf-life studies
- Microbiological testing and sterility testing
- Water testing — Purified Water, RO Water, WFI, Potable Water
- Packaging material testing
- Method validation and verification support
- Heavy metals, pesticide residues and contaminant analysis
- Certificate of Analysis (COA) review and compliance support
- Investigation support for NSQ (Not of Standard Quality) products
- Regulatory sample testing coordination for government and industry
Regulatory Authorities
- NABL-Accredited Laboratories
- Government Public Testing Laboratories
- FSSAI / CDSCO / State Drug Testing Authorities
Testing Categories Covered
- Tablets, Capsules, Syrups, Injections, Ointments, Eye/Ear Drops
- Veterinary Drug Products
- Packaged Foods, Dairy, Beverages, Edible Oils
- Spices, Condiments, Nutraceuticals, Health Supplements
- Creams, Lotions, Face Washes, Shampoos, Hair Oils, Soaps
- Personal Care and Cosmetic Products
Legal & Regulatory Enforcement
Legal, Regulatory & Enforcement Support Services
Drugs & Cosmetics Act · NDPS Act · GMP Compliance · Court Matter Support
IMEX Consultancy Services provides expert consultancy and professional support in matters related to the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, Medical Devices Rules, 2017, Cosmetics Rules, 2020, NDPS Act, 1985, and other applicable healthcare regulations. We assist pharmaceutical manufacturers, distributors, retailers, importers, healthcare institutions, and legal professionals in regulatory compliance, enforcement matters, and legal proceedings.
- Regulatory compliance assessment and gap analysis under Drugs & Cosmetics Act
- Guidance on licensing requirements and statutory obligations
- Support for regulatory inspections and investigations
- Assistance in responding to show-cause notices and regulatory communications
- Assistance in product recall, risk assessment and corrective actions
- Support in matters relating to Not of Standard Quality (NSQ) drugs
- Technical assistance for cases under the Drugs & Cosmetics Act
- Preparation of regulatory and technical case documents
- Assistance in drafting replies, representations and applications
- Expert review of laboratory reports and regulatory findings
- Guidance on statutory provisions related to drug sample analysis
- Assistance in review and interpretation of Government Analyst Reports
- Support for re-analysis and sample challenge procedures as permitted by law
- Risk-Based Inspection (RBI) readiness assessments and Revised Schedule M audits
- CAPA (Corrective and Preventive Action) development and implementation
- NDPS Act compliance — licensing, record management and controlled substance handling
Regulatory Authorities
- FDCA / State Drug Control Authorities
- CDSCO (Central Drugs Standard Control Organisation)
- Narcotic Drugs & Psychotropic Substances (NDPS) Regulatory Bodies
Areas of Expertise
- Drugs & Cosmetics Act, 1940 Compliance
- Medical Devices Rules, 2017 Matters
- Cosmetics Rules, 2020 Compliance
- NDPS Act, 1985 Regulatory Support
- GMP / Revised Schedule M Audits
- Court Matter & Legal Documentation
- NSQ Drug Investigations
- Risk-Based Inspection Preparedness
Clinical Research & Stability
Clinical Research, SMO & Stability Study Services
ICH · WHO · CDSCO · GCP · NABL-Accredited Labs
IMEX Consultancy Services offers comprehensive Clinical Research, Site Management Organization (SMO), Cosmetic Product Evaluation, and Stability Study services for Pharmaceutical, Cosmetic, Nutraceutical, Medical Device, and Healthcare companies. We provide scientific, regulatory, and operational support to ensure compliance with applicable national and international guidelines.
- Clinical Trial Planning, Coordination and Protocol Review
- Ethics Committee submission assistance
- Clinical Trial Site Identification and Management
- Subject Recruitment, Retention and Informed Consent Management
- Clinical Monitoring, Quality Oversight and Data Documentation
- Clinical Study Report (CSR) preparation
- Pharmacovigilance and Adverse Event Reporting support
- BA / BE (Bioavailability / Bioequivalence) Study Coordination
- Post-Marketing Surveillance and Real World Evidence (RWE) Studies
- SMO: Site Setup, Regulatory Binder Preparation and Study Close-Out
- GCP Compliance, Site Training and Investigator Coordination
- Dermatological Safety, Skin Irritation and Preservative Efficacy Testing
- SPF / Sunscreen Evaluation and Cosmetic Claims Substantiation
- Stability Study Protocols — Long-Term, Accelerated, Intermediate, Photostability
- Ongoing Stability Program Management and Shelf-Life Determination
- Stability Data Review, Trend Analysis and Regulatory Documentation
Regulatory Authorities
- CDSCO (Central Drugs Standard Control Organisation)
- ICMR / Ethics Committees
- NABL-Accredited Laboratories
- ICH / WHO Guidelines
Products & Sectors Covered
- Pharmaceutical Formulations
- Cosmetics and Personal Care Products
- Medical Devices
- Nutraceuticals and Health Supplements
- Herbal Products
- Veterinary Products
The IMEX Advantage
Why Manufacturers Choose IMEX
Experienced Regulatory Professionals
Our team comprises seasoned pharmaceutical regulatory experts with deep hands-on experience across CDSCO, FSSAI, and State FDA frameworks.
Practical & Compliance-Oriented
We deliver solutions that are grounded in real regulatory practice — not just theory. Every recommendation is actionable and audit-ready.
End-to-End Project Execution
From initial feasibility to final license approval, we own the entire process — so you can focus on building your business.
GMP, QA & Regulatory Expertise
Specialised knowledge across GMP, Regulatory Affairs, Quality Assurance, and Licensing ensures zero compliance gaps in your submissions.
Timely & Cost-Effective Services
We work to your timeline and budget — with parallel processing of documentation and regulatory submissions to minimise delays.
Ready to get licensed?
Speak with a regulatory expert — free initial consultation.