We can provide skills and services not easily found in Europe, including:

• Deep understanding of the EU regulatory landscape and its complex environment
• Deep understanding of the XEVMPD and the dramatic consequences that ISO IDMP and the new Pharmacovigilance legislation will bring to the pharmaceutical industry
• 15 years of practical experience
• A practical, hands-on approach to IT technology
• Design and development of product databases, tracking tools, and document management systems in the pharmaceutical industry with a focus on Regulatory Affairs and Pharmacovigilance
• Our solutions are web-based and can be used on mobile devices
• Hands-on help for companies in implementing various IT systems
• Practical knowledge of registering medicinal products and medical devices
• Clear vision and understanding of the needs of pharmaceutical companies
• Extensive experience with the validation of IT systems according to FDA 21 CFR Part 11

We are also engaged in the development of the current eCTD guidelines and the Next Major Version of eCTD 4.0 - RPS (Regulated Product Submissions), the Common European Submissions Platform (CEPS), and the new Pharmacovigilance requirements - relating to Article 57 and ISO IDMP on the EU level through our work at EGA (European Generic Medicines Association).

Group Sector

• Project management

• Pharmacovigilance

• Medical devices

• IT

• Regulatory

• Electronic submission

Geographical Area

• United Kingdom, German speaking Europe, Switzerland, Central Europe

Contact

• Vito Strasberger, Managing director
  vito.strasberger@nanokinetik.com