Medical and Technical Writing Services
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Expert Writing Support for Regulatory and Scientific Documents
Research Insights ā Clear Documentation ā Expert Writing
Pharmaceutical and Biologics Writing Clinical and Regulatory
- Literature Review
- Clinical Study Reports (CSR)
- Investigator Brochures
- Clinical Protocol
- Informed Consent Forms (ICF)
- Clinical Summaries (IND, NDA, ANDA, BLA, MAA, CTA)
- Briefing Packages
- Orphan Drug Applications
- Pediatric Investigation Plans
- Annual Reports
Labeling
- Core Data Sheet (CDS)
- Regional Labeling
- Pregnancy and Lactation Labeling (PLLR)
Safety
- Periodic Safety Update Reports (PSUR)
- Development Satety Update Reports (DSUR)
- Periodic Benefit and Risk Evaluation Reports (PBRER)
- Risk Management Plans (RMP)
- Patient Safety Narratives
- Periodic Adverse Drug Experience Report (PADER)
Medical Communication and Publications
- Articles, Abstracts
- Brochures, Patient / HCP Educational Material
- Marketing and Promotional Material, Training Content
Diagnostics and Medical Devices Writing
- Protocol
- Clinical Performance Plan
- Clinical Evaluation Plan
- Clinical Evaluation Reports (CER)
- Investigational Device Exemption (IDE)
- Performance Evaluation Reports (PER)
- Intended Use Statements
- State of the Art Determination (SOTA)
- Scientific Validity Report (SVR)
Technical Writing
- Chemist Manufacturing and Controls (CMC) / Module 3 Writing
- Standard Operating Procedures
- Development Reports
- Validation Reports
- Master Batch Records
Medical and Technical Writing Services for Regulatory Success
Why Clients Choose Pharma Wizard for Technical Writing
- Access global markets with reduced complexity, time, and cost
- Biopharmaceutical specialists and scientists with proven global CMC and clinical experience
- Extensive experience across complex product categories and therapeutic areas
- Evidence-based, thorough literature search enabling structured and accurate communication
- Health authority engagement experience across multiple countries for a global regulatory perspective
- Customer-focused, flexible services and solutions
- Flexible business models: project-based, managed services, and FTE staffing options
- Hybrid local-centralized support across safety functions
FAQS
What are different type of documents authored through medical and Technical writing?
Medical Writing requires professionals and clinical and regulatory background who author high quality clinical and regulatory documents for multiple purposes based on clinical data available through studies or literature review and regulatory guidelines. Medical writing helps prepare documents for clinical development such as clinical study reports, investigator brochures, protocols, clinical summaries. For safety purposes, documents such as periodic safety update reports, development safety update reports etc. For patient communication and safety purpose, core labelling documents and educational and promotional materials are prepared using medical writing.
Technical writing requires Chemistry Manufacturing and Controls professionals who can develop reports and documents for SOPs, development and validation reports, regulatory filings and other requirements.
Pharma Wizard provides medical and technical writing services to meet the regulatory requirements from global health authorities.
How do you support Medical Writing for multiple countries?
Pharma Wizardās team includes medical writing professionals based in multiple regions including the USA, Europe and Asia. Our team members have experience (10ā20+ years) authoring critical documents supporting complex therapies through development, launch and post market support.
What challenges do companies face in medical and technical writing and how do you address them?
Both medical and technical writing require a solid command on the subject and proven experience across therapeutic area, clinical development, comprehensive literature search and review strategy, CMC experience, preparation of analytical reports and others. It also requires ability to analyse the data and present in structured format acceptable by international standards. Proficiency in language and ability to communicate effectively suitable to the audience and the purpose of the document is key. Organizations worldwide often lack one or more of these capabilities. Besides, the requirement for medical and technical writing could be short to mid term where companies may need the professionals for few months and therefore, they need external support to augment resources to meet immediate requirements.
Pharma Wizard addresses these challenges by providing flexible, budget friendly and timely pharmacovigilance services including LQPPV using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.
How do you work with global pharma and devices companies for medical writing?
Pharma Wizard offers flexible business models suitable to diverse company sizes, project and resources requirements, regions and therapy areas. Our business models include project based, long term managed services, staffing model (both onsite and offsite) in a economic pricing model.
