Global Regulatory Affairs Services For Life Sciences

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.

Pharma Wizard’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.

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.