Technical Medical Writing

Medical and Technical Writing Services

In-Depth, Evidence Based Global Medical and Technical Writing for Pharmaceutical, Biologics, Medical Devices and Diagnostics.

Services We Offer

Expert Writing Support for Regulatory and Scientific Documents

Patient safety and quality of products (pharmaceutical, biologics, medical devices, diagnostics) depending significantly on quality of medical and technical documents throughout the development of the products as well as post market. Artixio’s experienced clinical and regulatory professionals have helped leading companies and CROs worldwide in developing well researched, evidence-based, high quality documents to ensure product compliance, patient safety and clear communication to the intended users.

Research Insights → Clear Documentation → 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

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

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
Regulatory Filings

Access Global Markets with Reduced Complexity, Time and Cost

Our 300+ Regulatory and Market Access experts based centrally and regional countries across 70+ key global markets have helped thousands of pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements and veterinary products successfully register and maintain compliance. Coupled with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by managing the regulatory strategy seamlessly across the product development and commercialization value chain.

Why Clients Choose Artixio?

Biopharmaceutical specialists and scientists with proven global CMC and Clinical Experience
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Evidence Based thorough literature search for structured communication
Health Authority Experience with multiple countries for global perspective
Intelligence driven, global regulatory services supported by Dvarka
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Safety functions

FAQS About Medical & Technical Writing

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.

Artixio provides medical and technical writing services to meet the regulatory requirements from global health authorities.

How do you support Medical Writing for multiple countries?

Artixio’s team includes medical writing professionals based in multiple regions including the USA, Europe and Asia. Our team members have experience (10-20+ 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.

Artixio 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?

Artixio 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.