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.
OUR TRUSTED CUSTOMERS
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 Experience
Drug License
Medical Device Licences
Cosmetics Licenses
Our Services
Our highly experienced team provides the following seamless services to help you with your project
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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Our Work
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
Very comfortable, Supportive, available 24 hours for any query. Thanks for designing our OSD & Dry Injection Beta Lactum Facility.
Ours was in old unit, Pharmadocx Team modified it & we got WHO-GMP & COPP Certificates in target time.
“Pharmadocx Consultants is the most experienced and technical sound personal, deep knowledge about drug laws, Pharmacopea and Plant layouts, every aspect of Pharmaceutical, Nutraceutical and Cosmetic industry is covered by him. I remember him for quality services of pharmaceutical consultancy.”
Latest Blog Posts
8 Step Guide to FDA 510(k) Pathway for Unclassified Devices
The primary focus of FDA 510(k) pathway is Class I and Class II medical devices. However, medical devices that lack formal classification may still be eligible for 510(k) clearance. Unclassified devices can still follow the FDA 510(k) pathway, if a legally marketed...
CDSCO Mandates Risk Classification for Class A and B Medical Devices & IVDs
Recently, CDSCO has issued a notice reminding State Licensing Authorities (SLAs) that manufacturing licenses for Class A and B medical devices and IVDs must be issued only after verifying the device’s risk classification in the CDSCO’s official list. Notably, issuance...
Understanding the MDSAP Audit Cycle: A Comprehensive Guide
The Medical Device Single Audit Program (MDSAP) is one comprehensive audit for meeting the regulatory requirements of multiple participating countries. Achieving regulatory harmonization across different regulatory industries will help manufacturers easily launch...