Company intelligence
Evnia
MedTech, BioTech & Pharma Regulatory and Clinical Compliance, R&D and Investments
About Evnia
Evnia provides the Medical Device, Pharma and Biotech industries with specialised consulting services in the areas of Regulatory Affairs/Compliance, R&D and Management by transforming data and regulations into measurable actions and tailored solutions. Key know-how and services include: - Clinical Evaluation Reports - Clinical and Technical Documentation - In Vitro Diagnostics (IVDR), Performance evaluation Plans/reports (PEP/PERs) - Regulatory and Project Management and external sourcing activities - Regulatory Compliance for Authorities globally - Clinical Experience Data We serve the Life-Sciences Industry and promote patient care and quality of life by striving, seeking and finding solutions that support compliance and R&D decisions in investments, innovation and medical/regulatory communications.
Verified activity
Signals from Evnia
8 published signals
Customers & Market
Evnia offers UK representation services for medicines and healthcare products.
Reported by Evnia
Partnerships
Evnia announced a strategic cooperation with SALIMANDER Medical & Consultancy.
Reported by Evnia
Legal & Regulatory
Evnia is involved in the consultation process for the Egyptian Drug Authority regarding the draft Technical Guidance for eCTD Submissions in Egypt, from 2 September to 14 October 2026.
Reported by Evnia
Legal & Regulatory
Evnia's company noted that on 31 August 2026, the U.S. Securities and Exchange Commission and the FDA signed a Memorandum of Understanding establishing a framework to exchange non-public information about FDA-regulated products, firms and activities.
Reported by Evnia
Partnerships
Evnia welcomed initiatives like DIGICAP, working alongside MedTech and biotech and investors backing them.
Reported by Evnia
Legal & Regulatory
Evnia reports that China's revised Good Clinical Practice for Drug Clinical Trials entered into force on 1 September 2026, replacing the 2020 version.
Reported by Evnia
Legal & Regulatory
Evnia's ANSM has adopted a decision creating a new interface committee with notified bodies designated in France under MDR and IVDR to improve working together between French competent authorities and notified bodies.
Reported by Evnia
Legal & Regulatory
Evnia advises healthcare professionals and facilities to adopt the new SAP application form and secure transmission tool as Health Canada will accept SAP medical device applications only through these methods as of 1 February 2027.
Reported by Evnia