Schedule-M Compliance Deadline Approaching for Pharmaceutical Manufacturers! We can help your factory achieve Schedule M Compliance.
Pharmaceuticals, CDSCO, Medical Devices, Cosmetics & WHO-GMP Consultation 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, 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 MD-5, MD-9 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
Medical Devices Regulatory 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
- Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Delhi Office - G-12, Pearls Best Heights-I, 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
ISO 13485 Certification for Class A and B Medical Devices
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...
How to Identify a Predicate Device? A Detailed Guide
Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...
US FDA 510(k) Dossier Preparation: Everything You Need to Know
510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...