India Regulatory Services

Biological Sample- ICMR
Manufacturing Plant Set Up Service
Medical Device
- Assistance on MDAC Meetings
- Australia Regulatory Due Diligence for Medical Devices
- Canada Regulatory Due Diligence for Medical Devices
- Clarification Letter / No Objection Certificate for Medical Devices
- Clarification Regarding Medical Devices from CDSCO
- E-waste EPR Registration Post compliance In India
- EPR Authorization Certificate from CPCB in India
- EU Regulatory Due Diligence for Medical Devices
- Investigational New Device/ New Device – First Time In India
  - Manufacture/Import New Medical Device License India – CDSCO Form MD 26 & MD 27
  - Permission to Conduct Clinical Investigation for Investigational Medical Device (Form MD-23)
  - Permission To Import/Manufacture Medical Device Without Predicate Device
- Medical Device – For Manufacturers
  - Free Sale Certificate from CDSCO for regulated Medical Devices
  - Permission for Loan License to Manufacture Class A & B Medical Devices (Form MD 4, 6)
  - Permission for Loan License to Manufacture Class C & D Medical Devices (Form MD 8, 10)
  - Permission for Test License to Manufacture Medical Device (Form MD-12, Form MD-13)
  - Permission to Manufacture Class B Medical Devices in India – MD-3 & MD-5
  - Permission to Manufacture Class C & D Medical Devices in India – MD-7 & MD-9
  - Permission to Manufacture or Permission For Loan License to Manufacture Class A & B Medical Device in India from State FDA (Form MD-5 and Form MD-6)
  - Permission to Manufacture or Permission for loan license to manufacture Class C & D Medical Device in India from CDSCO (Form MD-9, Form MD-10)
  - Retention of Loan Manufacturing License for Class A and B Medical Devices in India – MD 4 & MD 6
  - Retention of Manufacturing License for Class C and D Medical Devices in India – MD 7 & MD 9
  - Test license to Manufacture Medical Devices (Form MD 12, 13)
- Medical Device ISO 13485 Certification Assistance
- Medical Device Label Compliance
- Medical Device- For Importers
  - Amendments in Registration Certificate
  - Authorized Agent Support – Medical Device – CDSCO
  - Authorized Agent/ Registration Holder | Medical Device
  - Import License for Medical Devices (Form 10)
  - Import License from WPC in India
  - Marketing Authorization- New Medical Device (Form 44 & 45)
  - Permission For Test License To Import Medical Device (Form MD-16, Form MD-17)
  - Permission To Import Medical Devices License CDSCO Form MD14 MD15
  - Permission To Import Medical Devices Test License, India Form MD 16, MD 17
  - Post Approval Changes for Medical Device INMD-108
- Permission to conduct clinical investigation
- Pre-Conception & Pre-Natal Diagnostic Techniques Certificate in India – Form A & Form B
- Registration Number for Class A, Non – Sterile and Non-Measuring medical devices in India
- Registration Number for Non-Notified Medical Devices in India
- SUGAM Registration-MD/ IVD
- UKCA Regulatory Due Diligence for Medical Devices
- US Regulatory Due Diligence for Medical Devices
Diagnostic Kit
- Assistance in ISO 13485 Certification in India
- Clarification Letter / No Objection Certificate for In-Vitro Diagnostic Kit (IVD)
- Clarification Regarding Diagnostic kits From CDSCO
- Diagnostic Kit – For Importers
- Diagnostic Kit – For Manufacturers
- EPR Authorization Certificate From CPCB (For Battery) In India
- EPR Authorization Certificate From CPCB (For E-waste) In India
- EPR authorization certificate from CPCB in India
- In-Vitro Diagnostic Kits Label Compliance
- New In-Vitro Diagnostic First Time in India
  - Permission to Conduct Clinical Performance Evaluation for New In-Vitro Diagnostic (Form MD-25)
  - Permission to Import/Manufacture New In-Vitro Diagnostic which does not have a Predicate Kit (Form MD-29)
- Performance Evaluation from NIB
- Permission to conduct Clinical Performance Evaluation in India – MD 24 & MD-25
- Registration For Non-Notified In Vitro Diagnostic
- Risk Based Classification
Drug
- Drug- For Importer
- Drug- For Manufacturer
Cosmetics Importer
Food
- Approval of Non Specified Ingredients/ Products – For Food Supplements & Nutraceuticals
- Authorized agent support – Food – FSSAI
- Food Compliance
- FosCos FSSAI Food License & Registration in India – Form A and B & C
- FSSAI Advertisement & Claims Approval – For Food Supplements & Nutraceuticals
- FSSAI Annual Return Filing in India
- FSSAI Food Claim Approval
- FSSAI Food Compliance for Food Supplements & nutraceuticals
- FSSAI Form C for Food Supplements and Nutraceuticals
- FSSAI License Renewal in India
- Import Assistance
- Import License Holder
- Licensing and Registration
- Modification in License (Central/State) in India – Form & Non-Form C
- Non Specified Product / Ingredient Approval in India – Form I & Form II
- Product Approval
- Registration of Foreign Food manufacturing facilities (ReFOM) in India – Form 16 & Form 17
- Sanitary Import Permit (only for products which contain animal product or animal, veterinary drugs etc.)
CRO
Narcotics Regulatory Affairs
Biologicals
- Biologicals- For Importers
- Biologicals- For Manufacturers
Cosmetic
- Cosmetic Sample Testing
- Cosmetic- For Importer
- Cosmetic- For Manufacturer
  - Cosmetic Manufacturing License
- Cosmetics Label Compliance
- Labeling Assistance
- Permission To Import / Manufacture New Cosmetics – COS 12, COS 3
Wireless Planning and Coordination
Phytopharmaceutical Drug
Legal Metrology Services
- Legal Metrology Label Compliance
- Model Approval
- Registration of Importer under Rule 19 in India
- Registration of Manufacturers, Importers and Packers (Packaging and Warehouse Registration) under Rule 27
Exploring Functional Food Supplements: A Manufacturer’s Handbook
Medical Device for Importer
Navigating Functional Food Supplements: A Comprehensive Guide for Importers
Regulatory Services for Manufacturers
- Class A and B Medical device
- Medical Devices Class C & D – The lifeline of Healthcare Industry
- New Medical Devices – The lifeline of Healthcare Industry
Cosmetics for manufacturer
Drug for Importer
In-vitro Diagnostic IVD for manufacturer
- In-Vitro Diagnostics Class A & B
- In-Vitro Diagnostics Class C & D – The lifeline of Healthcare Industry
- New In-vitro Diagnostics – The lifeline of Healthcare Industry
BIS Standards
- BIS certification for domestic manufacturer in India – Form V
- BIS certification for foreign manufacturer in India – Form V
- BIS CRS for domestic manufacturer for electronic and IT Products in India – Grant Letter & Form I
- BIS CRS for Foreign manufacturer for electronic and IT Products in India – Grant letter & Form I

Drug for Importer