Precision-Tailored Regulatory Compliance Services
- Registration of technical files for medical devices and IVDR in every country for all continents
- CE technical files in Europe
- Registration of medical devices in the USA:
- 510 (k) applications,
- Premarket notification
- De Novo applications
- PMA
- Annual renewal
- Registration in Canada, including eCTD
- Registration is available in Mexico, Central America, Latin America, China, Japan, India, Russia, Taiwan, Bosnia, Serbia, Thailand, Malaysia, Indonesia, Singapore, Australia, the UK, Vietnam, Korea, the UAE, KSA, Qatar, Kuwait, Bahrain, and Oman, among others.
- Biocides registration and BPR registration file
Not Only That, We Offer
- Clinical evaluation reports (including literature search and analysis, and database research)
- Clinical studies support
- Biological safety assessment studies and report
- Regulatory watch
- Post-market surveillance with a plan and report, with database research.
- Product development from A to Z, including defining the testing needed for any product
- Process validation
- Responding to the questions from authorities and the FDA for any compliance-related questions
- Risk Analysis for products and processes
Our Compliance Solutions Don’t End Here! We Also Offer
- Cosmetic products registration worldwide, including Europe and the USA, among others
- Being an authorized representative
- Being a US agent for MoCRA
- Define regulatory strategy
- Point of contact for Notified Body and regulatory authorities
- CLP expertise consulting
- REACH expert consulting
- Prop 65 compliance
- Gap assessment analysis for standards
- Market access studies with regulatory costs estimation
We Are Experts
Our Specialized Quality Assurance Services
- Creating and updating the Quality Management System (QMS), According to ISO 13485, ISO 9001, and Quality Management System Regulation (QMSR)
- Complaints handling and treatment
- External and internal audits
- Suppliers audit
- Assistance in obtaining certifications, such as ISO 13485, ISO 9001, and Halal certifications, for export purposes.
- Responding to requests for compliance from regulatory bodies and the FDA.
- Managing incident reporting and recalls
contact
Contact Us Now
Get In Touch And Experience the AmberLife Standard!
Partner with consultants who treat your success as their mission.
- 469-875-7333
- lionab27@yahoo.com
- City, State or "Remote-based Services Available Nationwide"