Pharmaceutical companies & Contract Research Organisations (CROs)

  • Clinical Trial Documents for all clinical trial phases and study designs
    • Study Synopses Development
    • Study Protocols: Review and Amendments
    • Investigator’s Brochures (IBs) and Annual Updates
    • Informed Consent Form (ICF)
    • Patient Information Sheet (PIS)
    • Case Report Forms (CRFs)
    • Clinical Evaluation Report (CER)
    • Prescribing Information
  • Clinical Study Reports (ICH-E3 compliant)
  • Marketing Authorization Dossiers for Drug, Device and Biologics for all Regulatory Authorities including EMA, FDA, CDSCO, and emerging markets.
    • Clinical Sections of CTD submissions and expert statements
    • Non-clinical Sections of CTD submission and expert statements
    • Update and Gap analysis of various CTD components
    • Product Monographs
    • Prescribing Information (CDS, USPI, SmPC and LPDs)
    • Package Inserts (PI)
  • Response to Regulatory Authorities; Regulatory meeting briefing documents and related write-ups
  • Feasibility Survey Reports, Disease Demographics
  • Research & Publication Planning
  • Original Research Articles
  • Review Articles
  • Consensus Paper
  • Position Statement
  • Systematic Review
  • Meta-analysis
  • Network Meta-analysis
  • Case Reports / Series
  • Scientific Abstracts & Posters / e-posters
  • Brief Communications
  • Letter to Editor
  • Systematic Literature Search
  • Training Slide Decks, Training Modules
  • Product Appraisals
  • Data Presentations for Medical Conferences
  • Patient Information Leaflet
  • Physician Information Booklet
  • Leave Behind Leaflets
  • Continuing Medical Education (CME) Slide Decks
  • Sales Literature for Newly Launched Drugs
  • Standard Operating Procedures (SOPs)
  • Individual Case Safety Report (ICSR) Processing
  • MedDRA Coding of Adverse Event (AEs)
  • 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)
  • Study Newsletters
  • Healthcare Articles for Newspapers and Magazines
  • Web Content
  • App Content