Regulatory Compliance02BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
Explore serviceMulti-Market
Global Regulatory Compliance
One partner, one documentation strategy, every market you sell in.
Overview
What is Global Regulatory compliance?
Regulators around the world share the same scientific foundation in ISO 10993, but each has its own expectations, templates and areas of focus. Preparing separate documentation for every market is slow and expensive.
We build one coherent biological safety strategy that satisfies the US FDA, EU MDR notified bodies, CDSCO in India, and authorities across the Gulf and ASEAN regions, and adapt it to each submission.
Our work aligns with OECD GLP, ISO 17025 and NABL so that the laboratory data underpinning your submission is accepted wherever you file.
7+Regulatory frameworks
1Cohesive strategy
↓Duplicate work
When you need it
Typical triggers for this service
- Expanding a product into new markets
- Harmonising documentation across regions
- EU MDR transition from the Medical Device Directive
- FDA 510(k), De Novo or PMA biocompatibility sections
- CDSCO registration and Indian MDR 2017 requirements
What you receive
Deliverables
01Market-by-market requirements analysis
02Harmonised biological safety strategy
03Submission-ready biocompatibility sections
04GLP, ISO 17025 and NABL laboratory alignment
05Gap assessment of existing documentation
06Regulator query response support
Our approach
How we run the engagement
01
Market mapping
Target markets, device classification and regional expectations.
02
Gap assessment
Existing evidence reviewed against each market’s requirements.
03
Harmonised strategy
One evidence package designed to satisfy all markets.
04
Regional adaptation
Documents tailored to each authority’s format and focus.
05
Ongoing support
Query responses, renewals and post-market updates.
Standards & guidance
Aligned with
US FDAEU MDR 2017/745CDSCO · Indian MDR 2017OECD GLPISO 17025NABLGulf & ASEAN
FAQs
Global Regulatory Compliance: common questions
The core science can be shared, but each authority has its own expectations. We build one evidence package and adapt the documentation for each submission.
Yes. We support biological safety documentation for CDSCO registration under the Indian Medical Device Rules, 2017.
In addition to the US, EU, UK and India, we support submissions across the Gulf and ASEAN regions.
Related services
Often combined with this service
Regulatory Compliance02
ISO 1497108Risk Assessment & Management
Full ISO 14971 risk management file preparation integrated with your biological safety documentation — from hazard identification to residual risk.
Explore service
ISO 10993-1:202501Biocompatibility Evaluation
Full biological safety assessment per ISO 10993-1:2025 for all device risk classes and patient contact types — from skin contact to long-term implants.
Explore serviceNeed global regulatory compliance for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
Get In Touch
Do You Have an Enquiry?
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