Our Services
As healthcare experts with practical international experience, we understand that each company has its own world. Every single one of our clients has different needs and strengths to offer to new countries. That is why each project is unique for us, and we thrive to come up with the best-personalized market entry solution.
At RMEDZ we provide services in the following:
Gap Analysis
Gap analysis review process that identifies data gaps in the facility and process. we start where others stop, knowing that international market success does require local expert knowledge and network.
At RMEDZ we perform gap analysis for following:
- Facility Registration
- Product Registration
- Quality Management system
Regulatory Services
All our experts possess extensive experience with more than 15 years in the healthcare industry, we bring a global understanding of regulatory challenges to every client, every time.
We provide following Regulatory Services:
- Legal/Local agent
- Label Assessment
- Product Classification
- Pre-Market Notification
- Product Registration
- Product life cycle management (Variation/Renewals)
Quality Assurance Services
We believe that the best quality system is one that provides effective control while driving continuous improvement in efficiency and eliminating redundancy.
We offer you our world-class quality system services in the following:
- ISO and cGMP implementation
- Quality performance analysis
- Quality System Documentation
- Audit and inspection Readiness
- Risk management
Management System Certification
RMEDZ has extensive experience in management and certification, we strive to increase the value to our clients in the way we conduct our audits.
We deliver the following Management System Certification Services:
- ISO 9001:2015 QMS
- ISO 14001:2015 Environmental Safety
- ISO 13485:2016 Medical Devices
- ISO 22000:2018 Food Safety
Industry Specific Certification
Industry Certification is a process of program evaluation ensuring that individual programs meet industry standards in the respective areas. Industry certification represents the top of program quality.
We deliver the following Industry Specific Certification Services:
- KOSHER Certification
- HALAL Certification
- BRC – Food Safety Certification
- HACCP – Hazard Analysis & Critical Control Points
- ISO GMP Certification
Product Specific Services
Our qualified and dedicated team focuses on providing quality product certification services to our clients around the globe. Quality is the most important part of our company’s value system.
We deliver various Product Certification Services in following:
- CE Marking Certification
- FDA Food Registration
- FDA Device Registration
- FDA Drug Registration
- FDA Cosmetics Registration
- FDA 510k Notification
Organic Product Certification
Organic certification verifies that your farm or handling facility located anywhere in the world complies with the organic regulations and allows you to sell, label, and represent your products as organic.
We deliver following Organic Certification services:
- USDA NOP
- ECOCERT
- NATURLAND