PHARMADOCX CONSULTANTS is a leading Indian regulatory and compliance service provider, offering comprehensive solutions to pharmaceutical, medical device, cosmetics, and food manufacturers across India. Established to streamline the complex regulatory landscape for healthcare and life sciences businesses, the firm has rapidly evolved into a trusted consultancy for licensing, certification, plant setup, and project documentation services.
Core Business
At the core of Pharmadocx Consultants lies a mission to facilitate faster market entry and regulatory compliance for manufacturers in regulated sectors. The company’s expertise spans:
- Regulatory Compliance and Licensing: Covering drugs, cosmetics, nutraceuticals, and medical devices.
- Factory Layout and Plant Setup: Providing custom GMP-compliant factory layouts and end-to-end project support.
- Certification Support: Including WHO-GMP, CDSCO, ISO 13485, and US FDA 510(k) submissions.
- Detailed Project Reports (DPRs): Technical and financial feasibility documentation tailored to Indian and international regulatory frameworks.
Specialisation and Unique Value Proposition
Pharmadocx Consultants distinguishes itself through:
- Comprehensive Regulatory Knowledge: Their ability to manage multi-disciplinary licenses such as CDSCO MD5, MD9, and MD15, along with cosmetics, homeopathy, and food categories.
- Factory Setup Experience: Real-time GMP layout design services for new pharma, cosmetic, and device manufacturing plants.
- Turnkey Licensing: Fast-track application and documentation management with direct coordination with regulatory authorities.
Target Market
The company caters to:
- SMEs and startups in pharmaceuticals and medical devices initiating new manufacturing ventures.
- Established manufacturers expanding into new product categories or markets.
- Export-oriented companies seeking global certifications such as WHO-GMP and US FDA approvals.
Capabilities
- Multi-sector Licensing: Capable of securing licenses for drugs, cosmetics, medical devices, food supplements, and homeopathy.
- Regulatory Documentation: Generation of precise project reports, SOPs, quality manuals, and process validations.
- Design & Layout: GMP-compliant layout services for different factory types.
- Software Tools: Offering proprietary tools for QMS management and regulatory tracking.
Financial Overview
While the company’s exact financial figures are private, Pharmadocx Consultants demonstrates strong operational scale. The company has provided consulting services to over 750 clients across India, including well-known pharma hubs like Baddi, Ahmedabad, Hyderabad, and Sonepat.
Shipment and Regulatory Track Record
Pharmadocx has supported dozens of exporters in achieving WHO-GMP and US FDA 510(k) certifications, enabling international product shipments to markets like Southeast Asia, the Middle East, and Africa. Although not directly a manufacturer, its indirect contribution through clients includes more than 100 documented international regulatory approvals for drug and device products.
Certifications and Compliance
The firm assists clients in acquiring:
- WHO-GMP Certificates
- CDSCO Class A, B, C, D Licenses
- ISO 13485 Certification for medical devices
- US FDA 510(k) submissions
- Compliance with MoCRA (Modernization of Cosmetics Regulation Act)
- Schedule M, MDR 2017 compliance frameworks
Client Testimonials
- “Pharmadocx helped us establish our factory layout and obtain our first WHO-GMP certification within 4 months. Their DPR and licensing support is unmatched.” — CEO, Baddi-based Pharma Startup
- “From CDSCO to ISO 13485, we didn’t need to look anywhere else. Everything was handled professionally.” — Operations Head, Medical Device Manufacturer, Gujarat
Achievements
- Assisted in the setup of 100+ manufacturing units across India.
- Helped clients acquire over 300 CDSCO licenses.
- One of the few Indian firms supporting MoCRA compliance for cosmetics exporters to the US.
- Regular speaker and exhibitor in regulatory and pharma trade events in India.
Pharmadocx Consultants continues to be a trusted partner for businesses navigating India’s complex regulatory ecosystem, enabling faster go-to-market strategies and assured compliance for domestic and international trade.
