Product Life Cycle Support

LIFE CYCLE SUPPORT

We offer customised information solutions for all stages of product’s life-cycle and therapeutic categories.
We utilise the expertise of our trained professionals to provide services pertaining to clinical research, regulatory and pharmacovigilance writing.

Clinical Research

  • Clinical Trial Protocol
  • Investigator’s Brochure (IB)
  • Clinical Study Report (CSR)
  • Clinical Evaluation Report (CER)
  • Case Record Form (CRF)
  • Informed Consent Form (ICF)
  • Patient Information Sheet (PIS)

Regulatory Writing

  • CTD Modules 2.5 Clinical Overview
  • CTD Modules 2.7 Clinical Summaries (ISS/ISE)
  • CTD Modules 5.2 Tabular listings of Clinical Studies
  • CTD Modules Non Clinical Sections (2.4, 2.6 and 4.0)
  • Label Preparation (CDS, USPI, SmPC and LPDs)
  • Package Inserts (PI)
  • Structured Product Labelling (SPL)

Pharmacovigilance

  • Development Safety Update Report (DSUR)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Annual Safety Report (ASR)
  • Risk Management Plans (RMP)
  • Risk Evaluation and Mitigation Strategies (REMS)