Global Regulatory&Compliance Solutions for Medical Devices, IVDs&Pharmaceuticals
Seamless global approvals for CE Marking, ISO 13485, MDSAP, USFDA 510(k), CDSCO Licensing, ESG compliance & Pharma Registrations
ABOUT BIZSOLUTION
BizSolution is a global regulatory and compliance partner for Medical Devices, IVDs, and Pharmaceutical manufacturers, delivering end-to-end support—from documentation to certification and market approvals.
We help manufacturers achieve CE Marking, USFDA 510(k) clearance, CDSCO approval, ISO certifications, MDSAP and maintain ongoing compliance through structured, audit-ready systems.
Our team includes expert auditors, documentation specialists, and regulatory strategists with deep international experience.
WHY CHOOSE US
• Expertise in EU MDR, IVDR, ISO 13485, MDSAP, USFDA 510(k), CDSCO
• Strong and complete documentation: Technical Files, Design Dossiers, PER, RM, PMS, PMCF
• Proven success with Notified Bodies&Global Authorities
• Tailored regulatory pathways for start-ups&established companies
• Audit-ready documentation&QMS systems
• Integrated ESG&Sustainability solutions for healthcare industries
OUR CORE SERVICES
(1️) Medical Device Regulatory Services
• USFDA 510(k) Submission&Establishment Registration
• EU MDR Classification&CE Marking Documentation
• CDSCO Manufacturing&Import License Support
• Technical File, GSPR, PMS/PMCF Documentation
• Risk Management (ISO 14971)
• ISO 13485 QMS Setup&Implementation
• Internal&Supplier Regulatory Audits
• Regulatory Strategy&Roadmap Development
(2️) IVD Regulatory Solutions
• IVDR CE Marking support (Class A–D)
• Performance Evaluation&PER Documentation
• Technical Documentation (Annex II&III)
• Risk Management&Clinical Evidence
• Notified Body Submission Management
(3️) Pharmaceutical Regulatory Support
• Global Drug Product Registration
• CTD/eCTD Dossier Preparation
• BE Study Support&Stability Protocols
• Manufacturing License&GMP Compliance
• Variations, Renewals&Lifecycle Management
(4️) ESG & Sustainability Compliance
• ESG Framework&Policy Development
• Carbon Footprint Mapping&Reduction Planning
• Ethical Supply Chain Evaluation
• Workforce&Social Responsibility Systems
• ESG Reporting&Sustainability Documentation
• Compliance with Global Sustainability Standards
GLOBAL MARKET EXPERTISE
We support manufacturers across: US • EU • UK • India • Middle East • Australia • Canada • ASEAN • Africa