EU MDR & Notified Body Submission Support & Approval
- Technical Documentation
- NB Communication & Queries
- End-to-End Approval Support
- EU MDR/IVDR Compliance
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OUR SERVICES
Comprehensive Regulatory Solutions
End-to-end regulatory and compliance support for Medical Devices, Pharmaceuticals, Biotechnology, and Healthcare organizations across global markets.
- ExpertiseDriven
- CompliantProcess
- FasterMarket Access
From Compliance to
Global Opportunities
OUR SERVICES
End-to-End Regulatory & Compliance Support
We provide specialized regulatory consulting services throughout your product lifecycle, ensuring quality, compliance, and faster time-to-market.
FDA 510(k) & PMA Submission Preparation
- Gap Assessment & Strategy
- Submission Documentation
- Regulatory Correspondence Support
- Labeling & UDI Compliance
View ServiceTechnical File Compilation
- Design & Development Documentation
- Risk Management & Verification/Validation
- Labeling & IFU Documentation
- Submission-Ready Files
View ServiceRisk Management
- Risk Identification & Analysis (ISO 14971)
- Risk Management
- Risk Management Report
- Usability & Human Factors Support
View ServiceClinical Evaluation & Post-Market Surveillance
- Clinical Evaluation (CEP)
- Clinical Evaluation Report (CER)
- Post-Market Surveillance (PMS)
- Literature Search & Clinical Data Analysis
View ServiceRemote / Onsite Audit Services
- ISO 13485 & QMS Audits
- Supplier & Process Audits
- Audit Preparation & CAPA Support
- Virtual & Onsite Audit Assistance
View ServiceISO 9001 Quality Management System
- ISO 9001 QMS Implementation & Transition
- Plan-Do-Check-Act (PDCA) Process Framework
- Risk-Based Process & Core ISO 9000 Principles
- Internal Audits & Certification Body Readiness
View ServiceRegulatory Project Coordination & Global Submission Management
- End-to-End Project Management
- Multi-Country Submission Strategy
- Regulatory Agency Liaison
- Submission Tracking & Timelines
View ServiceGeneral Regulatory, Labeling & IFU Compliance
- Global Regulatory & Normative Compliance
- Post-Market Surveillance & Vigilance
- Product Lifecycle Management
- Regulatory Updates & Change Management
View ServiceIndia: CDSCO Regulatory Support
- Medical Device Registration (MD-12, MD-14)
- Import & Manufacturing Licensing
- MD-41 & MD-42 Licence Work
- CDSCO Documentation & Liaison
View ServiceBiocompatibility Studies
- Cytotoxicity Testing (ISO 10993, Part 5)
- Sensitization & Intracutaneous Testing
- Implantation & Hemocompatibility Studies
- Genetic & Systemic Toxicity Testing
- Pyrogen Testing (ISO 10993, Part 11)
- Customized Biological Evaluation Studies
OUR APPROACH
A Structured Process for Regulatory Success
We follow a streamlined and collaborative approach to ensure efficient and successful regulatory outcomes.
Understand
Assess your product, requirements & target markets
Plan
Develop a tailored regulatory strategy
Execute
Prepare, review, and submit with expert support
Achieve
Regulatory approval and faster market access
GLOBAL REGULATORY EXPERTISE
Support for Key
Global Markets
Expertise in Class I, II, and III Medical Device Regulatory Submissions and Market Access across global markets.
Canada(Health Canada)
FDA(USA)
CE Marking(EU)
ANVISA(Brazil)
India(CDSCO)
PMDA(Japan)
TGA(Australia)
BUILT TO CURRENT STANDARDS
EU MDR 2017/745Regulatory Gap Assessment
MEDDEV 2.7/1 Rev. 4Clinical Evaluation & Post Marketing Surveillance
ISO 14155Clinical Investigation (CIP)
ISO 14971Risk Management
ISO 10993Biocompatibility Studies
EN ISO 11607Packaging Validation
ISO 9001Quality Management System
21 CFR Part 820 — FDA QMSRFDA QMSR Gap Assessment
ISO 13485ISO 13485 Gap Assessment
ISO 14644Cleanroom Classification
ISO 11135 — EO SterilizationEO Sterilization Gap Assessment
ISO 11137 — Radiation SterilizationRadiation Sterilization Validation
Pricing & Offer
Launch packages from 1/10th standard market pricing with accelerated timelines.
Book a Free Consult – Contact us today!
Need Expert Regulatory Support?
Launch packages from 1/10th standard market pricing with accelerated timelines.
Book a Free Consult – Contact us today!
- Experienced Team
- Global Regulatory Reach
- Flexible Engagement Models
- Confidential & Secure
- On-Time Delivery