Regulatory Affairs

The registration of a product is an essential part of the business strategy and our Regulatory Affairs Experts can support from the beginning in giving guidance on strategically important points, in order not to get surprises at the point of collating the submission dossier or technical file. The decades-long experience with different risk-classes of medical devices, i.e. class I, II and III, on the EU (according to MDD and MDR medical device regulation) and the US-market is beneficial in the support of the clients. Our Experts are constantly balancing time, requirements and costs of the clients in addition to fully understand health authorities’ requirements. An early onboarding of our Experts assures an optimal Regulatory Affairs support with a high probability of success when registering medical devices, combination products and pharmaceuticals, or in the case of audits.

Expertise and Experience in Regulatory Affairs:

  • Establishing Regulatory Strategy
  • Conducting Regulatory Due Diligence
  • Authoring of Clinical Evaluations according to MEDDEV  2.7.1 Rev. 4
  • Authoring of Submission Dossiers, such as technical files, design file dossiers and CTDs
  • Support during CE marking, 510(k) clearance and medical device or combination product approval
  • Support during Scientific Advice and Designation meetings
  • Audit Preparation incl. mock audits and unannounced audits
  • Support during Health Authority Audits
  • Assessing medical device Classifications
  • Customer-specific training (in-house or as eLearning)

We have supported:

  • Scientific Advice meetings for medical devices and combination products
  • Designation meetings for medical devices and combination products
  • Regulatory Strategy for medical devices, in-vitro diagnostics and combination products
  • Support in CTD compilation for combination products and pharmaceuticals
  • Mock-Audits for medical devices, in-vitro diagnostics, combination products and pharmaceuticals
  • Health Authority interactions and support in communication for high potent drugs, narcotics and anesthetics (schedule 1 drugs)
  • Strategical consultancy for post-market surveillance and vigilance initiatives
  • Design and implementation of surveillance and vigilance processes, incl. optimization and support
  • Support during health authority communication and field actions
  • Customer-specific training

Why Avanti Europe is the right address:

For Regulatory Affairs support, Avanti Europe is the right address as we hold the following critical certification and skill sets:

  • Certified Regulatory Affairs Expert (RAC, MTOPRA or equivalent)
  • Pragmatic approach to complex regulatory settings
  • Goal oriented
  • Bespoke service and timely delivery of results
  • Interdisciplinary network of experts

Contact us to explore our skill-set and discuss your projects or ad-interim staffing needs.