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Expert regulatory consulting services for Medical Devices, IVDs, Pharmaceuticals, Cosmetics, and Digital Health. From import licenses to ISO certifications, we ensure complete compliance and smooth market entry.

Contact Info
Phone

+91 982 117 0493

Email

info@medireg.in

Location

646, Varun Enclave, Sector 28, Noida, UP-201301.

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ADVANCING REGULATORY COMPLIANCE

Empowering healthcare and life science businesses with expert regulatory solutions. From medical devices and pharma to digital health and cosmetics, we simplify approvals, ensure compliance, and accelerate your journey to market across India and South Asia.

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Regulatory Expertise

Our specialists bring deep knowledge of CDSCO, BIS, NPPA, and global standards to ensure accurate, compliant, and efficient regulatory pathways for your products.

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End-to-End Solutions

From product classification and documentation to approvals and post-market compliance, we provide complete regulatory support under one roof.

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Faster Market Access

We streamline approval processes and minimize delays, helping your medical devices, pharma, and healthcare products reach the market quickly and efficiently.

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TRUSTED REGULATORY CONSULTING PARTNER

imgAbout Our Company

Simplifying Regulatory Compliance for Healthcare & Life Sciences

MediReg Solutions India LLP delivers specialized regulatory and compliance services for medical devices, pharmaceuticals, cosmetics, and digital health industries. We help businesses navigate complex regulatory frameworks, secure approvals, and achieve faster market access across India and South Asia. With a focus on accuracy, efficiency, and compliance excellence, we act as a reliable partner throughout your product lifecycle.

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Regulatory success rate across approvals & submissions

500K+

Projects Successfully Delivered

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“Expert regulatory guidance that ensures compliance, reduces risk, and accelerates your product’s journey to market.”

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MediReg Experts

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imgOur Services

Comprehensive Regulatory
Solutions for Healthcare Industries

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Trusted by healthcare businesses across India & South Asia

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Regulatory Approvals & Licensing

End-to-end support for CDSCO approvals, import licenses, registration certificates, and market authorization for medical devices, pharma, and cosmetics.

imgImport License imgMarket Authorizatione
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Compliance & Certification

Ensure full regulatory compliance with ISO 13485 QMS implementation, BIS certification, NPPA registration, and WPC approvals.

imgISO 13485 imgBIS & NPPA
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Documentation & Technical Dossiers

Professional preparation and review of technical files, design dossiers, clinical evaluation reports, and regulatory documentation.

imgTechnical Files imgClinical Reports
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95%

Successful Regulatory Approvals

10+

Years of Industry Expertise

500+

Projects Successfully Delivered

200+

Clients Across India & South Asia

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Expert Regulatory Guidance

We provide precise regulatory strategies and expert guidance to help businesses navigate complex approval processes with confidence and accuracy.

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Client-Focused Solutions

Every project is tailored to your specific needs, ensuring efficient compliance, faster approvals, and seamless support throughout your product lifecycle.

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Need Regulatory Assistance?

+91 982 117 0493
imgOur Projects

Regulatory Success Stories
Across Healthcare Industries

Medical Device Import Licensing

Medical Devices // CDSCO Approval

Medical Device Import Licensing

Successfully assisted international manufacturers in obtaining CDSCO import licenses for seamless entry into the Indian market.

ISO 13485 QMS Implementation

Compliance // Certification

ISO 13485 QMS Implementation

Implemented quality management systems for medical device manufacturers ensuring compliance with global standards.

Pharmaceutical Product Registration

Pharma // Regulatory Submission

Pharmaceutical Product Registration

Managed end-to-end dossier preparation and submission for pharmaceutical products across Indian regulatory authorities.

Cosmetic Product Compliance

Cosmetics // Registration

Cosmetic Product Compliance

Assisted brands with regulatory approvals, labeling compliance, and market entry strategies for cosmetic products.

Digital Health (SaMD) Compliance

Digital Health // AI/ML

Digital Health Compliance

Provided regulatory strategy and technical documentation support for AI/ML-based medical software solutions.

BIS Certification & WPC Approval

Certification // Compliance

BIS & WPC Certification

Guided clients through BIS certification and WPC ETA approvals for regulated electronic medical equipment.

Insecticide Product Registration

Agro Products // Licensing

Insecticide Registration

Delivered regulatory support for insecticide product approvals, documentation, and licensing compliance.

FMCG Product Compliance

Food & FMCG // Regulatory

FMCG Regulatory Compliance

Supported FMCG brands with regulatory approvals, labeling standards, and compliance requirements for Indian markets.

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imgWhy Chose Us

Simplifying Complex Regulations with Expertise & Precision

Navigating regulatory frameworks can be challenging. At MediReg, we combine industry expertise, deep regulatory knowledge, and a client-focused approach to deliver seamless compliance solutions for healthcare and life sciences businesses.

  • img Expertise in CDSCO, BIS, NPPA & Global Standards
  • img End-to-End Regulatory & Compliance Support
  • img Faster Approvals with Strategic Planning
  • img Customized Solutions for Every Industry

Regulatory Success Rate

95%
Learn More
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Trusted regulatory experts delivering accurate, compliant, and efficient solutions for healthcare industries

Learn More
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imgClient Testimonials

What Our Clients Say About Our Regulatory Expertise

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Rahul Mehta

Medical Device Importer

5.0

"MediReg made the entire CDSCO approval process smooth and hassle-free. Their expertise saved us time and ensured quick market entry."

“HIGHLY PROFESSIONAL SERVICE”

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Anjali Sharma

Pharmaceutical Consultant

5.0

"Their team handled our product registration and documentation with precision. We highly recommend MediReg for regulatory compliance."

“TRUSTED REGULATORY PARTNER”

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Vikram Pate

Cosmetics Brand Ownerr

5.0

"From compliance to approvals, MediReg provided end-to-end support. Their guidance helped us launch our products confidently in the market."

“EXCELLENT COMPLIANCE SUPPORT”

imgFAQ’s

Common Questions About Regulatory Services

Find answers to common questions related to regulatory approvals, compliance, and licensing for healthcare, pharma, and medical device industries.

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+91 982 117 0493

info@medireg.in
  • Do I need regulatory approval for my medical device or product?
    Yes, most medical devices, pharmaceuticals, cosmetics, and related products require regulatory approval before being marketed in India. We help determine your product classification and guide you through the entire approval process.
  • What regulatory services does MediReg provide?
    We offer services including CDSCO approvals, import licenses, ISO 13485 implementation, BIS certification, NPPA compliance, technical documentation, and post-approval regulatory support.
  • How long does the regulatory approval process take?
    The timeline depends on product type, classification, and regulatory requirements. With our expertise, we streamline documentation and submissions to reduce delays and ensure faster approvals.
  • Do you support foreign manufacturers entering the Indian market?
    Yes, we provide in-country representation services and assist foreign manufacturers with product registration, import licensing, and compliance requirements in India.
  • Who can benefit from your services?
    Our services are ideal for manufacturers, importers, startups, and established businesses in medical devices, pharmaceuticals, cosmetics, digital health, and FMCG sectors.
Regulatory Services
Medical Device Registration
Compliance Services
CDSCO Approvals
Pharma Services
Pharma Regulatory Services
Consultation
Get Free Consultation
ISO Services
ISO 13485 Implementation
Import License
Import License Assistance
BIS Certification
BIS Certification
Consultation
Talk to Experts
Documentation
Technical Documentation
SaMD
Digital Health (SaMD)
Compliance
Regulatory Compliance
Consultation
Start Your Approval Process
Cosmetics
Cosmetic Product Registration
FMCG
FMCG Compliance
Insecticides
Insecticide Registration
Consultation
Expert Regulatory Support