integris3 BioSolutions

intelligent integrated solutions delivered with integrity



Compliance

Negotiating the regulatory pathway in new territories – NAFTA, EU, LATAM, MEA


Regulatory Affairs

  • Regulatory Strategy & Consulting
  • NDA, ANDA, CMC, BLA, DMF (US, Canada), ASMF
  • Global / Country Specific Submissions
  • eCTD publishing
  • Artwork and labels
  • Medical Labelling
  • CCDS / CCSI Authoring and Periodic Updates
  • SDS – Safety Data Sheets
  • Clinical Trial Assessment/Elucidation
  • REMS
  • REACH
  • Regulatory authority meeting preparation and facilitation
  • Chemistry Manufacturing & Controls (CMC)
  • Regulatory intelligence
    • Lifecycle Management Support
    • RX to OTC

Pharmacovigilance

  • Literature search
  • ICSRs
  • MedWatch assessments
  • Risk management (REMS)
  • Research Analytics and insights
  • Site Registrations
  • GPVP training

Medical Writing

  • Scientific Writing
  • Clinical Publications
  • Regulatory / Technical Writing
  • Labelling Creation / Updates
  • Clinical Trial Disclosures
  • Health Economics and Outcomes

Compliance

  • Pre-Inspection Audits
    • cGMP evaluations
    • cGLP evaluations
    • cGCP evaluations
    • cGPVP assessments
  • SOP writing
  • Translations
  • NDC code
  • Safety Assessment
  • ISO Evaluations
    • 9001-2015
    • 22176
    • 14385
  • OSHA Evaluations
  • USDA Evaluations – APHIS
  • Advice on Certifications – Organic, Ecocert, Local (NJ)
  • Intellectual Property

Resourcing/Staffing

  • Clinical Operations
  • Biostatisticians
  • Clinical Research Associates
  • Clinical Data Management
  • Regulatory Affairs
  • Medical Affairs

US FDA Agent Services

  • Handle all FDA communications (from routine to emergencies)
  • Registration and Listing (from establishment to labeler)
  • Submissions (eCTDs, NDAs, ANDAs, DMFs, CBEs etc.)
  • Self-Identification for Generic Facilities
  • Drug Labelling (Rx and OTC)
  • Full US Agent capabilities

Contact us now to develop and implement a strategy that will harness your intellectual property’s full potential