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+91 9990179529
+91 9868679414
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Email
info@grenax.in
Regulatory Affairs
The process of taking products from laboratory to market is a complex one involving lots of uncertainties due to ever-evolving regulatory framework. It is essential for every business to have a sound regulatory strategy for every product which will not only ensure timely launches but also helps in maintaining effective lifecycle of the products. Managing Regulatory Affairs is a specialty task, which requires a perfect balance of various skills such as knowledge, experience and ability to connect with regulatory officials.
We offer following regulatory affairs solutions for Indian market:
- Clinical Trial (Phase I, II, III)
- Post Market Surveillance (Phase-IV / PMS / APMS)
- Subject Expert Committee Meetings
- Import License for Clinical Trial
- Export of Plasma Samples for Research
- Clinical Trial Management
- Investigational New Drug (IND) Applications
- New Drug Approval (NDA) Applications
- Subsequent New Drug (SND) Applications
- Fixed Dose Combination (FDC) Applications
- Clinical Trial Waiver Applications
- Subject Expert Committee Meetings
Market Authorization
- Registration Certificate in Form-41
- Import License in Form-10
- Retail & Wholesale License (Form-20/21/20B/21B) for Drugs
- Import License in Form-11
Import & Registration
- Special Code/Neutral Code for export
- Export NOC for Drugs
- Free Sales Certificate
- Certificate of Pharmaceutical Product
- Written Confirmation
- Embassy Attestation
- Export Authorization for NDPS
- Export NOC for Precursor Chemicals
Export
- Manufacturing License in Form-25 / 28 for Pharmaceuticals
- Renewal of Mfg. License in Form-26 for Pharmaceuticals
- Repacking / Re-labeling NOC
- WHO-GMP Certification
- Test License in Form-29 / CT
- Manufacturing License for Synthetic Narcotics & Psychotropic Substances
Manufacturing License
- Risk-based classification of Medical Device or IVD
- Test License for manufacture of Small Quantities for Testing and/or Analysis
- Market Authorization Application to State Licensing Authority (SLA) for Low Risk Devices
- Market Authorization Application to Central Licensing Approval Authority (CLAA) for High Risk Devices
- Facility Inspection Support for License Approval
- Clinical Trial Waiver Application for CLAA Application
- Subject Expert Committee Meeting
- Testing of Samples at Govt. Notified Laboratory
- Non-Clinical Studies (Biocompatibility / Performance Evaluation Testing)
- Clinical Trial Management
- Post Approval Changes
- Line Extension of existing license
- Repacking / Re-labeling NOC
Manufacturing License
- Indian Agent Support / In-Country Representation
- Manufacturing Facility Registration
- Bureau of Indian Standards registration
- Risk-based classification of Medical Device or IVD
- Import License for Medical Device
- Retail & Wholesale License (Form-20/21/20B/21B)
- Test License for Import of Small Quantities for Testing and/or Analysis
- Testing of Samples at Govt. Notified Laboratory
- Post Approval Changes
- Line Extension for Licensed Products
- Addition of new products to existing Import License
- Import License Renewals
Import & Registration
- Manufacturing License in Form-32
- Loan License in Form-32A
- Product Classification
- Labeling Compliance Verification
- Non-Clinical Studies
- Clinical Trial Management
- Post Approval Changes
- Line Extension for addition of products
- Lifecycle Management
Manufacturer Of Cosmetics
- Indian Agent Support / In-Country Representation for Products Registration
- Product Classification
- Labeling Compliance Verification
- Registration Certificate in Form-42
- Post Approval Changes
- Line Extension of registered brand category
- Addition of new brands from registered facility
- Renewal of Registration Certificate
- Product Lifecycle Management