Challenges of Traditional Regulatory Intelligence Approaches

 

Traditional document-centric, multi-system, and manual knowledge management systems lead to inefficiencies and information loss in regulatory intelligence. This approach results in several challenges:

  • Decentralized monitoring of regulatory signals causes conflicting information and redundant efforts
  • Inefficient evaluation of signals by global team members, with manual forms and processes, takes time away from high-ROI activities
  • Current technology is not designed for specific scope, product, or geography monitoring, leading to missed critical signals or an overabundance of signals
  • Non-standardized and open loop processes for triage and impact assessments result in siloed knowledge

Redica Regulatory Intelligence Integrated in Veeva RIM

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Global Coverage

Comprehensive regulatory intelligence from around the world

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Automated Feeds

Deeply labeled, structured data enables access to relevant signals without noise and facilitates AI insights

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Integrated Workflow

Impact assessment workflow allows for efficient SME review and stakeholder dissemination

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AI-Powered Insights

Integrated AI capabilities for driving action and insights

 

Source Coverage

 

Redica Systems provides extensive coverage across multiple countries and product categories including Human Drugs, Biologics, Medical Devices, IVDs, and Animal Health. The platform also includes harmonization organizations like WHO, ICH, VICH, and various trade associations such as AAFCO, IFPMA, CEFIC: APIC, IPEC, MedTech Europe, PhRMA, PDA, AABB, EFPIA, ESGCT, Team NB, and DITTA.

 

Harmonization Orgs

  • WHO
  • ICH
  • VICH
  • PIC/S
  • IMDRF
  • OECD
  • ICMRA
  • INCB
  • EAEU/EEC
  • AHWP/GHWP
  • ASEAN
  • MERCOSUR
  • GCC
  • CIOMS
  • WOAH

 

Pharmacopoeia

  • Brazil
  • British
  • Chinese
  • European
  • EAEU (Eurasian Economic Union)
  • International
  • Indian
  • Japanese
  • WHO
  • ICH
  • VICH

 

Standards Body

  • WHO
  • IEC
  • AAMI
  • ASTM
  • NIST
  • ISO
  • ISPE
  • EBMT
  • ISP

 

Trade Associations

  • AAFCO
  • IFPMA
  • CEFIC: APIC
  • IPEC
  • MedTech Europe
  • PhRMA
  • PDA
  • AABB
  • EFPIA
  • ESGCT
  • Team NB
  • DITTA

 

 

Advanced Data Enrichment

Interested in the integration? Let us know: