Quality review tool

Automated corrections and template alignment by our in-house tools and experts reduce errors, expedite reviews, and ensure high-quality, accurate submissions. We assure quality-led review processes for Regulatory documents, ensuring consistency and compliance.

Quality review tool - Overview

Quality of documentation is the basis for any drug approval provided by Regulatory bodies. Ensuring that this documentation is consistent, accurate, and compliant with Regulatory agencies’ requirements, we at Freyr ensure all the Regulatory documents undergo stringent quality review processes.

Errors and inconsistencies in a document can lead to misinterpretation of the data and questions about the data's validity. At Freyr, we have developed an in-house quality review tool that helps us to enhance the quality review process ensuring quick turnaround time and high-quality documents.

The quality review tool enables us with the following:

  • Workflow process initiated for performing the quality review
  • Auto correction of formatting errors and spell check
  • Identify the data errors for correction
  • Alignment and adherence to the template requirements
  • Implementation of sponsor sponsor-specific style guide
  • Address review comments and closure of the quality review process

For more information on Freyr’s Quality Review tool, please feel free to contact us.

Quality review tool

  • Ensuring thorough management of the entire quality review workflow process
  • Assured effective review process
  • Expert team ensuring the alignment and adherence to required templates
  • Ensures uniformity in sponsor-specific style manuals
  • Ensures all feedback is incorporated effectively
Quality review tool
  • In-house tool designed to ensure high-quality documentation
  • Minimizes errors and inconsistencies to guarantee the validity of data
  • Streamlines the quality review process for quicker turnaround time
  • Automated function decreases manual efforts and expedites the review process
  • Provides thorough and effective quality reviews
Quality review 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​