Unlocking Success in Healthcare Governance, Risk, Compliance and Approval and Products Registration Processes.

We specialise in design, planning and exploiting strategic programmes and tactical in-field works for market registration of medical products and in-vitro diagnostics including government approvals in the United States of America, Canada, Brazil, Japan, Australia, Europe and the United Kingdom. We prioritise savings to streamline products, services, time and materials support for any involved stakeholder.

Market Approval Programmes

Design, planning, and execution of programmes for obtaining market approvals for medical devices, in-vitro diagnostics, and pharmaceuticals.

Expertise in Medical Device Single Audit Programme (MDSAP) for streamlined approvals.

Management systems approvals, auditing, and ongoing support.

Regulatory Compliance Solutions

Streamlining processes and lobbying for regulatory matters and change management.

Assistance with CE and UKCA approvals for medical devices.

Expertise in MDSAP products, market, and site approvals.

Supply Chain Management

ISO harmonization approvals and support for ensuring compliance throughout the supply chain.

Third-party auditing services to enhance supply chain efficiency and transparency.

Accreditation and Implementation Support

Streamlining service offerings, planning accreditation processes, and facilitating in-field implementation for seamless operations.

Technology Transfer and Knowledge Sharing

Comprehensive technology transfer services and knowledge-sharing initiatives.

On-purpose upskill programmes to empower your team with the latest industry knowledge and expertise.

Regulatory Affairs Support

Regulatory affairs services encompassing market registration and product vigilance support to ensure compliance with all regulatory requirements.

Explore our range of innovative regulatory support for the healthcare and energy sectors including streamlined service delivery.

Our in-field and desk commitments to cutting-edge technology transfer ensure your operations stay ahead on day-by-day basis.