Narrative writing tool

Our narrative writing tool and services ensure the accurate and consistent patient safety narrative creation from various clinical data sources, enhancing Regulatory compliance. Our innovative solutions automate manual tasks, accelerating the submission process and improving data transparency.

Narrative writing tool - Overview

Narratives are created based on various sources of clinical data collected during the study. These sources include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, Data Clarification Forms (DCFs), and Clinical database listings. Drafting narratives manually presents numerous challenges, including resource constraints, inconsistencies in content, diverse data sources, and time-intensive processes.

At Freyr, we are committed to delivering innovative solutions that streamline the narrative writing process, enhance data transparency, and support Regulatory compliance. Our solutions automate time-consuming manual tasks associated with narrative writing, allowing your team to focus on strategic activities and accelerating the submission process.

Freyr has meticulously designed a narrative writing tool that will maximize the accuracy, consistency, and reliability of patient safety narratives for Regulatory submissions.

Contact us today to learn more about how our patient safety narrative solutions can elevate your organization’s Regulatory submissions and advance your drug development initiatives.

Narrative writing tool

  • Preparation and review of patient safety narratives
  • Quality control of the data and scientific information
  • Vast experience across multiple therapeutic areas like oncology, neurology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
Narrative writing tool
  • Complete understanding of the critical importance of patient safety narratives in Regulatory submissions
  • Defined processes of thorough scientific, medical, editorial, and in-house quality control review before the sponsor review
  • Expertise in patient safety narratives
Narrative writing tool

Celebrating Customers Success

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​