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Regulatory Medical Writing Services
Unlock pathways to your successful Regulatory documentation with PharmaWizard’s expert medical writing services right before the submissions. From Clinical Overviews to Occupational Risk Assessment Reports, we ensure precision and compliance with global Regulatory standards..
60+
Experts
20+
Years of Total Experience
150+
Customers/Clients
250+
Projects
100+
Dossiers Authored and Reviewed
200+
Clinical Overviews
80+
RPI Updates
2000+
PDE Reports
Regulatory Medical Writing Services - Overview
Regulatory medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Developing accurate clinical and non-clinical documents for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough knowledge of the Regulatory guidelines.
PharmaWizard is a significant player in Regulatory Medical Writing Services and has vast expertise due to a team of highly qualified medical and scientific writing professionals. At PharmaWizard, well-established processes governed by SOPs, checklists, and reviews ensure that high-quality documents are maintained. Our Regulatory medical writing team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of medical writing experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.
Our medical writing team is well-versed in dealing with submissions for the US FDA, EMA, MHRA, and other regulated and semi-regulated countries.
PharmaWizard is a significant player in Regulatory Medical Writing Services and has vast expertise due to a team of highly qualified medical and scientific writing professionals. At PharmaWizard, well-established processes governed by SOPs, checklists, and reviews ensure that high-quality documents are maintained. Our Regulatory medical writing team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of medical writing experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.
Our medical writing team is well-versed in dealing with submissions for the US FDA, EMA, MHRA, and other regulated and semi-regulated countries.
PharmaWizardās Regulatory Medical Writing Services
Clinical Services
Optimize clinical submissions with our competencies
Non-Clinical Services
Our support; streamlined product development
Regulatory Toxicology Services
Resolve your toxicology imperatives with us
Clinical and Non-Clinical Consulting and Strategic Services
Maximize efficiency with our cohesive efforts
Automation in Medical Writing
Leverage our automation capabilities for efficient documentation
Regulatory Medical Writing Services for Medical Devices
- Expertise
- Advantages
- Strategic Regulatory writing that supports Clinical and Non-Clinical Development according to the submission type and health authority
- Preparation and review of Non-Clinical and Clinical Overviews and Summaries (eCTD Modules 2.4, 2.5, 2.6, and 2.7), including the preparation and review of eCTD Modules 4 and 5
- Preparation and review of the Clinical Study Report (CSR, eCTD Module 5)
- Preparation and review of the Clinical Trial Protocol (CTP), Investigator Brochure (IB), efficacy and safety summaries, and patient/safety narrative writing
- Support for Integrated Summaries (ISS, ISE, and ISI)
- Clinical justification documents for the EU, US, and other emerging Regulatory markets
- Biowaiver support for product approval and strategic support for study design
- Abuse liability assessment justification support
- Clinical (GCP) and bioanalytical (GLP) facility audits provide expertise and support for study-specific monitoring
- Toxicological Risk Assessment (TRA) of impurities, extractable and leachables, excipients, and industrial chemicals
- Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations
- A team of over sixty (60) medical writing experts, which includes clinical, non-clinical, and scientific writers
- In-depth Regulatory medical writing knowledge like the ICH-GCP, EMA, and FDA guidelines is perfectly integrated with IT capabilities
- A complete understanding of the complex drug development process, including NCEs, Generics, Biologics, and Biosimilars
- Vast experience in working across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Defined processes of thorough scientific, medical, editorial, and in-house quality control review before the sponsor review
- Experience in drafting medical writing documents for various phases of clinical development, including Phase I to IV, Post-Marketing Surveillance Studies (PMS), and Post-Authorization Safety Studies (PASS)
- Well-versed in working with various stakeholders alongside Regulatory Medical Writing teams like clinical operations, data management, biostatistics, medical, and safety to deliver documents
- Submission-ready medical writing documents in terms of technicalities, language, format, and templates used to prepare the documents
- Timely delivery of medical writing documents with the highest standard of qualit
