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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