CDSCO IVD Manufacturing Licence (MD 5)
MD 5 manufacturing licence for low- and moderate-risk in-vitro diagnostic (IVD) products.
Our Services
Regulatory, licensing and factory setup consultancy — under one roof.
From CDSCO drug and medical device licensing to US FDA 510(k), IVD approvals, MoCRA cosmetics registration and turnkey factory layout design, our integrated services help you launch and scale with confidence.
Service Categories
A complete portfolio for life-sciences manufacturers
Explore our services across pharmaceuticals, medical devices, factory layout design and specialised regulatory consultancy.
Pharma (Drugs)
Complete regulatory and compliance support for pharmaceutical manufacturers — from licensing to certification.
All Pharma Services
Single-window consultancy covering plant design, licensing, QMS and certification for pharmaceutical manufacturers.
Schedule M Compliance
Gap assessment and facility upgrade to fully comply with the Revised Schedule M with minimal disruption.
Drug Manufacturing Licence
End-to-end CDSCO drug manufacturing licence support, including Form 25 and Form 28 filings.
WHO GMP Certification
Documentation, gap analysis and audit support to secure WHO GMP certification for export readiness.
Loan Licence
Hassle-free loan licence applications for organisations manufacturing through third-party facilities.
Quality Management System (QMS)
WHO-aligned QMS implementation with SOPs, risk management plans and staff training.
Test Licence
Form 29 test licence support for R&D, stability studies and clinical trial samples.
Project Report
Investor-ready project reports covering market analysis, capex, machinery and financial projections.
COPP
Certificate of Pharmaceutical Product (COPP) support to enable smooth product registration in export markets.
Pharma Detailed Project Report (DPR)
Comprehensive DPR with feasibility, plant sizing, costing and ROI analysis tailored to your product mix.
Medical Devices
Full regulatory pathway for Class A, B, C and D medical devices — from CDSCO licensing to US FDA 510(k).
All Medical Devices Services
Integrated consultancy for medical device factory setup, licensing, QMS and global market access.
CDSCO Import Licence
MD 15 import licence support for foreign manufacturers entering the Indian medical device market.
CDSCO Medical Device Registration
Product registration and notification support across all device classes under the Medical Devices Rules, 2017.
CDSCO MD 9 Manufacturing Licence
MD 9 licence application for Class C and D medical devices, including audit and documentation support.
CDSCO MD 5 Manufacturing Licence
MD 5 licence application for Class A and B medical devices, with state-level liaison and audit support.
US FDA 510(k)
Predicate identification, 510(k) submission and FDA query handling to achieve clearance efficiently.
Authorised Agent
Indian Authorised Agent representation for foreign manufacturers, backed by valid MD 42 licence.
Loan Licence
Loan licence support for medical device companies manufacturing through approved third-party sites.
CDSCO MD 13 Test Licence
MD 13 test licence for R&D, performance evaluation and clinical investigation of medical devices.
Medical Devices Detailed Project Report
Data-driven DPR for medical device manufacturing covering feasibility, capex, ROI and regulatory pathway.
ISO 13485
QMS implementation and documentation aligned to ISO 13485 for medical device manufacturers.
ISO 9001
ISO 9001 quality management system implementation, internal audits and certification readiness.
Layout Designing
Regulatory-compliant, scalable and efficient factory layouts for life-sciences manufacturing.
Pharma Factory Layout Design
GMP-compliant pharmaceutical plant layouts optimised for workflow, segregation and Schedule M compliance.
Medical Device Factory Layout
ISO 13485-aligned medical device facility layouts with cleanroom and utility planning.
Cosmetics Factory Layout Design
Hygienic, GMP-aligned cosmetics manufacturing layouts designed for capacity, safety and compliance.
Nutraceutical Factory Layout Design
FSSAI- and GMP-aligned nutraceutical facility layouts engineered for scalability and audit readiness.
Other Services
Specialised regulatory and consultancy services across cosmetics, AYUSH and turnkey plant setup.
Cosmetics Manufacturing Licence
COS-8 manufacturing and COS-2 import licence support under the Cosmetics Rules, 2020.
Homeopathic Medicine
Licensing, GMP and project planning support for homeopathic medicine manufacturers.
Plant Setup Consultancy
Turnkey plant setup — from land selection and machinery sourcing to commissioning and audits.
ERP Software for Pharmaceutical Industries
Digital tools and software solutions to streamline regulatory documentation and compliance workflows.
US FDA Cosmetics Registration India (MoCRA)
MoCRA-compliant facility registration, product listing and US Agent representation for Indian exporters.
IVD
In-Vitro Diagnostics (IVD) regulatory services
Specialised CDSCO licensing support for IVD manufacturers and importers across all risk classes.
CDSCO IVD Manufacturing Licence (MD 9)
MD 9 manufacturing licence for high-risk IVDs, including audit and documentation support.
CDSCO IVD Import Licence (MD 15)
MD 15 import licence for foreign IVD manufacturers entering the Indian diagnostics market.
Ready to advance your study
Partner with us to accelerate your drug development journey
From first-in-human trials to commercialization, our experts deliver the science, speed, and certainty pharma teams trust.