Do you have oversight of your SDEAs?

SDEAs are a focus area in PV inspections. In recent years, they have been one of the most common findings in MHRA PV inspections. Oversight issues are often triggered by:

  • Mergers & Acquisitions (M&As): When companies merge or are acquired, SDEAs must be updated to comply with new corporate standards as well as related standardized procedural documents
  • Business evolution: In global organizations, business relationships are continuously formed and contracts are signed, such as licensing agreements, supply and marketing agreements or distribution agreements. Frequently, obligations to patient safety are an afterthought, and PV departments must retain oversight of when SDEAs have to be created and ensure that SDEAs are up-to-date on both local and global levels
  • Changing regulatory landscape: Organizations need to ensure that safety related content in SDEAs is compliant with international and national legislation and regulation, depending on the territories and products subject to the contracts

Navitas Life Sciences Provides an Integrated Aproach Leading to Impactful Results

  • Assessment of current volume and type of agreements/ business relationships
  • Review of system landscape and configuration
  • Review, updates and development of Agreements

Deliverables

  • Establish a strategic management framework
  • Design and implement tailored governance model
  • Define standards, mechanisms, and metrics for management oversight
  • Clarify roles and responsibilities
  • Promote internal cross-functional and external stakeholder collaboration
  • Develop procedural documents and SDEA templates
  • Assess, evaluate, configure, and implement supporting technology
  • Consolidate document repositories
sdeaready

Benefits

  • Documents consolidated into a single, globally accessible repository
  • SDEAs reviewed and business relationships with Third Parties clarified
  • SDEA procedures and templates harmonized
  • System configured to produce metrics and reports for inspections and audits

Latest News

01
Dec2017

Navitas brings End – to – End R D Solutions to the Generic Drug Industry

Navitas Life Sciences, a TAKE Solutions Enterprise, provides services and technology to deliver “first...