Regulatory & Compliance
Full GMP compliance, ISO 13485, FDA 21 CFR Part 820 alignment
Ensuring compliance with GMP and ISO/FDA standards
Traceable documentation, QMS oversight, regulatory expertise
Being audit-ready for regulatory inspections
Regulatory guidance, dossier preparation, Notified Body interactions
Navigating global IVD registration requirements
Operate under Helio or client QMS, continuous monitoring
Adapting and integrating Quality Management Systems (QMS)
Turning Your Challenges into Results
From Regulatory Challenges to Compliance Excellence
Regulatory Compliance Ensured : IVDR transitions, 510(k), clinical trial assay approvals
Flexible QMS Support : integrate with client or Helio QMS, audits & documentation ready
Global Regulatory Expertise : international registrations, FDA pre-sub, IRB submissions
Your benefits with Helio
Regulatory Affairs supporting development in compliance with international regulations
Choose Helio for ...
Comprehensive Regulatory Affairs Support
Contract manufacturing compliant with GMP, ISO 13485, FDA 21 CFR Part 820, Japanese MHLW, MDSAP
Research Use Only, CE-marking, cGMP
Full documentation, traceability, and audit readiness
25+ years of experience interacting with Regulatory Agencies and Notified Bodies
Regulatory & GMP Compliance
Operate under Helio’s QMS or client’s QMS
Continuous monitoring, internal audits, and quality oversight
Regulatory guidance, dossier preparation, and audit support for global IVD registration
Feasibility Phase:
- Define global regulatory pathways (EU, US, Canada, Japan, Australia…) and help build analytical and clinical development roadmap
- Early interactions with Competent Authorities to validate development strategies, analytical and clinical study protocols
Development& V&V Phases
- Develop technical documentation compliant with international regulations
- Ensure robust evidence generation (Intended Use and submission)
Quality Management & Regulatory Support
Manufacturing Transfer Phase
- Ensure labelling and packaging compliance
- Support process validation, technology transfer, and batch record preparation
- Verify supplier qualification and raw material compliance
- Maintain traceability and documentation readiness for audits
Post-Market Documentation & Filings
- Support post-market surveillance, vigilance, and reporting
- Prepare annual product reviews and updates
- Manage changes and deviations under regulatory frameworks
- Facilitate renewal and maintenance of registrations with Competent Authorities and Notified Bodies