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Medical Writing
Reg and Post Marketing
Clinical Writing
Scientific Writing
Reg and Post Marketing
- Variations/amendments, Renewals and Annual updates
- Manufacturing summaries
Process validation reports - Author/update labeling documents (CCDS, SmPC, USPIs, PILs) per PLR and QRD Template and other applicable guidelines
- Author/update periodic reports (PSURs, DSURs, PADERs, PBRERs, CARs)
- Safety Updates, Risk Management Plan (REMS, RiskMaps, EURMP) and Risk Benefit assessments
- Summary Bridging Reports and Ad-hoc reports
Clinical Writing
- IBs, Study Protocols for CT and BA / BE studies
- CSRs (Full, Synopsis, Web Synopsis)
- Subject Narratives
- Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
- INDs ARs/DSURs
Scientific Writing
- Manuscripts and Abstracts
- Posters and Newsletters
- Patient Support Programs (PSPs) and Market Research Programs (MRPs)
- Create, update and maintain database for Standard Responses (FAQs)
- Research and Review articles
- Product Monographs
- Medical Rationale documents
- PPT Presentations and Conference grids
- Conference and KOL support
Quality Management Systems
QMS: We provide the gold standard in electronic quality and document management systems to streamline processes, templates, forms, checklists, trainings, records, assessments etc. consistently enhancing productivity while exceeding their expectations. We align with the organization’s purpose and strategic direction to provide the utmost of satisfaction.
Clinical Data Management
EDC: We provide a cost-effective, advanced solution that manages your clinical data. This in turn allows for a better understanding of the study through reporting and metrics tailormade to fit the needs of that trial.
Training
- Introduction to Pharmacovigilance
- Basics of Pharmacovigilance
- Pharmacovigilance Regulations
- End to End ICSR Case Processing
- Aggregate Report
- Signal Detection and Risk Management
We are also partnered with Temple University for their Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy
scientific support
KOL MANAGEMENT
- KOL Identification
- Faculty/ Participants Liaison
- Scientific modules
- Meeting minutes
- Executive summary
- Post-meeting consensus
- Transcription
