About Medral Global
Medral Global is an India-based compliance advisory firm simplifying regulatory processes for businesses in the healthcare and life sciences sectors. We provide end-to-end consultation and documentation support for:
Medical Gases
Pharmaceuticals (Formulations & APIs)
OUR SERVICES
Medical Devices, Pharma, Cosmetics, Ayurvedic Plant Setup and Licensing
Pharma
- Factory Design & Setup
- Schedule M Compliance
- Project Reports
- Machine Selection
- Test License, Loan License
- Regulatory Work
- Drug Manufacturing License
Medical devices
- Factory Design & Setup
- CDSCO MD5 License
- CDSCO MD9 License
- CDSCO Import License
- ISO 13485
- US FDA 510(k)
- CDSCO Class A Registration
Cosmetics
- Factory Design and Setup
- ISO Certifications
- Cosmetics Manufacturing License
Ayurvedic
- Factory Design and Setup
- AYUSH License
- WHO GMP and COPP
Our Services
Licensing
We handle complete licensing for Drug Manufacturing (Form 25, 28), Medical Devices (MD-5, MD-9), Cosmetics (Form COS-8), Nutraceuticals, and CDSCO Import Licenses.
Documentation
We prepare and maintain QMS documentation for ISO 13485, Schedule M, WHO-GMP, SOPs, validation records, Plant Master Files, and Device Master Files.
Designing
We design new plants and deliver detailed Civil AutoCAD layouts, electrical and plumbing drawings, HVAC plans, machine GA drawings, epoxy flooring layouts, and false ceiling plans.
Certification
We support certification for GMP, GLP, WHO-GMP, COPP, ISO 13485, Free Sale Certificates, CDSCO, DCGI, and FDA approvals.
Medical Devices Regulatory Services
MD5
MD5 License for Class A & B Devices
CDSCO license for manufacturing and selling Class A & B medical devices in India.
MD9
MD9 License for Class C & D Devices
CDSCO license for manufacturing and selling Class C & D medical devices in India.
MD15
MD15 Import License
Regulatory approval from CDSCO for importing medical devices into India under Form MD15.
MD13
MD13 Test License
Manufacturing license for medical devices issued by CDSCO for testing, evaluation, and training purposes.
Drugs License Services
Drugs Manufacturing License
End-to-end support for setting up pharmaceutical manufacturing units and obtaining Form 25 & Form 28 manufacturing licenses from FDA.
WHO GMP Compliance
Full-service support to achieve WHO GMP certification, ensuring your drug manufacturing meets global quality standards.
Factory Layout Designing
Expert services for Civil AutoCAD drawings, electrical, plumbing, HVAC, GA drawings, and epoxy layouts for pharmaceutical factories.
Other Services
Cosmetics Manufacturing & Import License
Complete assistance for setting up cosmetics manufacturing or import units and obtaining licenses on COS5 and COS7.
ISO Certification
Get expert help to achieve certifications like ISO 9001, ISO 13485, and more from recognized regulatory bodies.
Homeopathic Factory Consultant
End-to-end consultancy to establish homeopathic medicine plants in India and obtain a license on Form 25C from the State Drug Controller.
Our Works
Our Clients
What our loyal clients have to say
Medral Global helped us navigate the complex CE certification process for our medical devices. Their expertise, responsiveness, and detailed documentation made the entire journey seamless.
From regulatory strategy to audit preparation, Medral Global delivered exactly what we needed. Their knowledge of ISO standards is unmatched, and they truly care about our business goals.
We were launching a new IVD facility and Medral Global managed the entire turnkey consultation. Their insights and hands-on approach helped us stay compliant and launch on time.
Medral Global has been our go-to partner for regulatory compliance in the export market. Their tailored strategies helped us meet both EU and US standards efficiently.
