MEDICAL DEVICES / PHARMACEUTICALS / LIFE SCIENCES
REGULATORY AFFAIRS / QUALITY AFFAIRS / ENGINEERING
Your Trusted
Regulatory Partner for
Global Market Access
End-to-end regulatory consulting and compliance support for Medical Devices, Pharmaceuticals, Biotechnology, and Healthcare organizations.
- Efficient &Experienced
- AffordableSolutions
- FastTurnaround
- TrustedGlobal Partner
From Compliance
to Global Opportunities
Helping Life Science Innovations
Reach the World Safely and Faster.
ABOUT MEDSCAPE
Our Mission
To empower Medical Device, Pharmaceutical, Biotechnology, and Healthcare organizations by delivering reliable regulatory consulting, compliance management, and technical support services that ensure quality, integrity, and sustainable business growth.
QUALITY
INTEGRITY
COMPLIANCE
GLOBAL GROWTH
WHY CHOOSE MEDSCAPE
Proven Regulatory Expertise
Confidential & Secure Engagements
Flexible Engagement Models
Client-Centric Approach
On-Time Delivery
Cross-Functional Team Support
OUR SOLUTIONS
Comprehensive
Regulatory Solutions
Support throughout your product lifecycle with end-to-end regulatory and compliance expertise.
Labeling & IFU Compliance
Compliant labels, packaging, and Instructions for Use for global markets.
We help medical device manufacturers develop, review, and ensure regulatory-compliant labeling, packaging, and Instructions for Use (IFU) as per FDA, EU MDR, CDSCO, and other international requirements.
Label & Artwork Review
Preparation and review of product labels and packaging artwork.
IFU Compliance
Development and review of Instructions for Use (IFU) with clear, accurate, and compliant content.
UDI & Packaging Support
Support for UDI, barcodes, and packaging information as per regulatory requirements.
Country-Specific Requirements
Adaptation of labeling and IFU for USA, EU, India, and other target markets.
Label Change Management
Efficient management of label updates due to product or regulatory changes.
Regulatory Guidance
Guidance on symbols, warnings, precautions, and content as per applicable standards.
FDALabeling Compliance
EU MDRLabeling Compliance
CDSCOLabeling Compliance
GlobalMarket Support
INDUSTRIES WE SUPPORT
Providing skilled regulatory professionals for Medical Device, Pharma, Biotech, and Healthcare organizations.
Pharmaceuticals
Biotechnology
Healthcare
GLOBAL REGULATORY EXPERTISE
Expertise Across
Global Markets
Expertise in Class I, II, and III Medical Device Regulatory Submissions and Market Access across global markets.
- CE Marking (EU)
- FDA (USA)
- ANVISA (Brazil)
- Canada (Health Canada)
- PMDA (Japan)
- TGA (Australia)
- CDSCO (India)
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
WHAT YOU GAIN
- Systematic literature review & evidence grading (MEDDEV 2.7/1 Rev. 4)
- Clear benefit-risk rationale & residual risk alignment (ISO 14971)
- PMCF rationale, tools, and templates (ISO 14155-aligned)
- Device equivalence strategy when applicable
- Reviewer-style QA checks to reduce Notified Body (NB) questions
PROVEN ACROSS DEVICE TYPES
Implantable Products
Transient-Use Devices
Peripheral Intervention Products
Medication Injection Systems
Ophthalmic Devices
Combination Products
20/B/2, New Kallanatham Road,
Mulluvadi, Attur,
Salem, Tamil Nadu - 636141
GST Reg No: 33AXBPA6751A1Z8