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Comprehensive Medical Writing Services For Life Science Organisations
Our team of Medical Devices Global Regulatory Affairs and Pharmacovigilance CoE, offers end-to-end solutions to ensure that medical devices comply with regulatory requirements. The team of experienced regulatory and pharmacovigilance professionals understands the complex and ever-changing landscape of medical device regulations, and they are committed to guiding clients through the process from concept to post-market surveillance. The team offers a full range of regulatory and device vigilance services, including product classification, regulatory strategy and approach
- Regulatory Services
- Clinical Services
- Clinical Evaluation Reports & Planning
- Authorised Representative Services
- EU MDR & IVDR Remediation Consulting
- Quality And Compliance Services
- Medical Devices Labeling & Review
- Design History file - (DHF)
Comprehensive Medical Writing Solutions for Life Science Organizations
The medical writing team offers a full range of services to meet clients’ medical writing needs. The team of expert medical writers delivers high-quality, accurate, and timely medical writing services that meet regulatory requirements and exceed clients’ expectations. From clinical study reports to manuscripts, regulatory documents, and medical communications, the team offers a comprehensive suite of medical writing services that can be tailored to specific needs.
- capabilities
- Regulatory Services
- Clinical Services
- EU MDR & IVDR Remediation Consulting
- Quality And Compliance Services
- Artwork and Labeling
- Device Vigilance & PSUR writing
- Full and Functional Services with Customized support considering time and cost efficiencies
- CLINICAL AND NON CLINICAL SUMMARIES
- CLINICAL PROTOCOLS
- CLINICAL STUDY REPORTS
- QUALITY
- INVESTIGATOR'S BROCHURE
- PUBLICATION WRITING
- OVERVIEWS
- CLINICAL TRIAL.GOV AND EUDRACT