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MediReg Solutions India is a comprehensive regulatory consulting partner that helps healthcare and life science companies achieve compliance, secure approvals, and enter markets faster. With deep regulatory expertise and a strong track record, we support the entire product lifecycle—from strategy and documentation to certification and post market compliance.

Contact Info
Location

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

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Regulatory Approvals

Complete assistance for CDSCO approvals, ensuring smooth and compliant product entry into the Indian market.

Key Services

  • img CDSCO Licensing
  • img Market Authorization
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Market Authorization

End-to-end support for import licensing of medical devices, pharma, and healthcare products.

Key Services

  • img Registration Certificate
  • img Indian Authorized Representative for foreign manufacturers.
ISO 13485 ISO 13485
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ISO 13485 Implementation

Establish quality management systems to meet global standards for medical device manufacturing.

Key Services

  • imgQMS Setup
  • imgAudit Support
Documentation Documentation
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Technical Documentation

Preparation of technical files, design dossiers, and clinical evaluation reports for regulatory submissions.

Key Services

  • imgPrepare the technical docs as per licensing authority requirement
  • imgEstablish local clinical evaluation data
BIS BIS
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BIS & WPC Certification

Guidance for BIS certification and WPC ETA approvals for regulated electronic and medical devices.

Key Services

  • imgBIS Certification
  • imgWPC ETA
SaMD SaMD
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Digital Health (SaMD)

Regulatory guidance and documentation for AI/ML-based medical software and digital health products.

Key Services

  • imgAI/ML Compliance
  • imgTechnical Files
Pharma Pharma
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Pharma Regulatory

Complete regulatory services for pharmaceutical products including submissions and compliance.

Key Services

  • imgProduct Registration
  • imgDossier Preparation
Post Approval Post Approval
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Post-Approval Support

Ongoing regulatory compliance, renewals, and support to maintain approvals and business continuity.

Key Services

  • imgRenewals
  • imgRegulatory Updates
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imgClient Testimonials

What Our Clients Say About Our Regulatory Expertise

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”

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”

Vikram Patel

Cosmetics Brand Owner

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”

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