Consulting & Outsourcing Services

"We stand ready to support your organization in every aspect of PV system development"

Clinical Safety & Compliance

  • SUSARs Management
  • Medical adjudication of SAEs
  • Analysis of similar events(AoSEs)
  • Safety Management Plans (SMPs)
  • Authoring IBs, CSRs & DSURs
  • Review of scientific publications
  • Signal review
  • Medical Monitoring

  • Post-Market Safety & Compliances

  • ICSR intake, processing, and submission
  • Global and local literature monitoring
  • Signal detection and management
  • Eudravigilance and MHRA Portal Services
  • PSMF/National PSMF

  • Medical Writing

  • Benefit/Risk Reports
  • Aggregate reports- PSURs, PBRERs, DSURs, ACOs & PADERs
  • Risk management plans (RMPs) and REMS
  • Writing SOPs and technical documents – PV system setup
  • Writing product information, PILs, SmPCs, CCDS
  • Regulatory feedback

  • Regulatory Affairs

  • Regulatory Strategy Development
  • Regulatory Submissions
  • Compliance Management
  • Regulatory intelligence
  • Responses to Health Authorities

  • Medical Information MICC - Clini Resource

    Medical Information

  • Handling product Inquiry, Product complain & PQC
  • MICC
  • Emergency un blinding for Clinical trails
  • Subject Counselling
  • Customised responses to queries

  • Medical Devices & Veterinary pharmacovigilance

  • PMS system set-up
  • Incidents & Complaints Management
  • Field Safety corrective actions management
  • Annual PMS report & PSURs
  • Trend Analysis
  • Setting Up Veterinary Pharmacovigilance system and compliances

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