CDSCO, Medical Devices, Pharmaceuticals, Cosmetics & WHO-GMP Plant Setup and Licensing Services
We provide consultancy services for setting up Allopathic, Ayurvedic, Cosmetics, Medical Devices & Health Supplements/Nutraceuticals Industries in India. We provide regulatory services for grant of Drugs and Cosmetics Manufacturing License, CDSCO Medical Devices Manufacturing License, Import License, US FDA 510K Registration, CE, Health Canada MDL and MDEL Registrations, etc.
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We have years of experience helping a wide array of clients setting up their factories. Our firm has set-up maximum number of plants in North India.
Plants Set-up
Clients
Years
Drug License
Medical Device Licences
Cosmetics Licenses
Our Services
Designing
We do the designing of new plants and provide Civil Autocad Drawings, Electric drawings, Plumbing Drawings, HVAC drawings, Machine GA drawings, Epoxy drawings, False Ceiling Drawings, etc. Read more about Plant designing services we offer!
Licensing
We provide regulatory services for the grant of Drug Manufacturing License on Form-25,28, Medical Device Manufacturing License on Form MD-5, MD-9, Cosmetics Manufacturing License on Form COS-8, Nutraceutical License, CDSCO Import License
Documentation
We help in maintaining QMS Documents as per ISO-13485 for Medical Devices, Schedule-M documents, WHO-GMP documents, all types of SOP’s Validation Documents, Plant Master File, Device Master File
Certification
GMP, GLP, WHO-GMP, COPP, ISO-13485, Free Sale Certificate from CDSCO DCGI FDA
CDSCO Medical Devices Registration Services
We offer fast and specialized regulatory guidance and assistance in obtaining CDSCO licenses for medical devices, ensuring seamless compliance with India’s healthcare standards.
MD5 License for Class A & B Medical Devices
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MD9 License for Class C & D Medical Devices
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MD15 Import License for Medical Devices
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MD13 Medical Devices Test License
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Drugs License Services
Drugs Manufacturing License
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WHO GMP Compliance
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Factory Layout Designing
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Other Services
Cosmetics Manufacturing & Import License
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Homeopathic Factory Consultant
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Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
Phone / Whatsapp
Address
- Head Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Registered Office - Netaji Subhash Place, Delhi, 110034
OUR CLIENTS
Testimonials
What Our Happy Clients Say
Latest Blog Posts
How to Tailor MDSAP Audit Readiness Checklist for US Market?
The US FDA accepts MDSAP audits in lieu of routine inspections. Hence, a single MDSAP audit can demonstrate compliance with both ISO 13485:2016 and FDA’s Quality System Regulation (21 CFR Part 820). For manufacturers, this reduces the burden of undergoing separate FDA...
8 Key Differences Between MDSAP and ISO 13485 Certification
ISO 13485 is a global medical device quality management standard. On the other hand, MDSAP is a regulatory audit program built on ISO 13485 but extended to meet country‑specific requirements. Thus, ISO 13485 builds the QMS foundation whereas MDSAP verifies compliance...
US FDA 510(k) Review Process and Main Stages: A Guide
The FDA 510(k) review process is the most common pathway for bringing moderate-risk medical devices to the U.S. market. It is a structured pathway ensuring a medical device is substantially equivalent to a legally marketed predicate device before clearance. The...










