PharmXL offers a comprehensive suite of medical writing services, covering Clinical, Regulatory, and Drug Safety Reports. Our team receives regular training to maintain compliance with regulatory standards and ensure consistency in writing processes according to client requirements. Our commitment is to deliver high-quality services at competitive prices.
Clinical Evaluation Report
Investigator Brochures
Clinical Study Protocols
Informed Consent Documents
Patient Diary Cards
Case Report Forms
Clinical Study Reports
SAE Narratives for Clinical Study Reports
Patient Safety Narratives
Clinical Summaries/Product Feasibility Reports for Medical Devices
Common Technical Documents
Clinical and Non-Clinical Overviews
Summary of Product Characteristics
Pack Insert and Labels
Clinical Expert Statements
Briefing Documents
NDAs/ANDA/IND
Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS)
Literature and Brochure for Medical Devices
Annual Updates/ Annual Safety Reports
Periodic Safety Update Reports (PSURs)
Periodic Benefit Risk Evaluation Report (PBRERs)
Periodic Adverse Drug Experience Report (PADER/PAER)
Risk Management Plans (RMP)
Risk Evaluation and Mitigation Strategies (REMS)
Development Safety Update Reports (DSURs)
Manuscripts
Abstracts
Conference Slide Kits
Posters
Review Articles
Drug Monographs
Marketing Support and Training Materials
Marketing Meeting Reports
Promotional and Educational Material
Newsletters