Risk-Benefit Analysis

Our in-house processes ensure compliance with Regulatory requirements and guidelines by facilitating transparent documentation of risk-benefit analysis reporting. Freyr’s Medical writing team is equipped to assess the impact of different risk mitigation strategies and optimize benefit-risk profiles.

Risk-Benefit Analysis - Overview

At Freyr, we recognize the significance of thoroughly evaluating the benefits and risks associated with medicinal products to ensure patient safety and optimize the outcome of public health.

Our Experienced Medical Writing team analyzes the vast amount of structured and unstructured data, including clinical trial data, adverse event reports, and literature for scientific data with precise references, and helps sponsors to identify patterns, trends, and correlations relevant to benefit-risk assessments evaluating the safety and efficacy profile of medicinal products.

Through literature review, medical writers gather relevant scientific evidence for benefit-risk analysis and thereby expedite the evidence-based decision-making process.

Our in-house processes ensure compliance with Regulatory requirements and guidelines by facilitating transparent documentation of risk-benefit analysis reporting. Freyr's Medical writing team is equipped to assess the impact of different risk mitigation strategies and to optimize benefit-risk profiles.

We also have an AI-enabled in-house tool/system to support benefit-risk assessment and reporting.

Risk-Benefit Analysis

  • Qualified team members with in-depth knowledge of Regulatory requirements for evaluating the benefit-risk profile of medicinal products
  • Understanding of statistical methodologies for analyzing clinical data, also well versed with design and execution of clinical trials
  • Expertise in pharmacovigilance and risk management strategies
  • Familiar with the literature review and health economics and outcome research
  • Capability to interpret complex scientific data and communicate observations in clear and concise manner
Risk-Benefit Analysis
  • A team of experienced medical writers with expertise in clinical, non-clinical along with scientific background are able to provide in-depth guidance on the risk-benefit analysis reporting.
  • Analyze the benefit-risk assessments backed with scientific evidence and evaluate the safety and efficacy profile of medicinal products.
  • The expertise of the Freyr team and AI-enabled in-house tool/system enables us to assess the impact of different risk mitigation strategies and optimize benefit‑risk profiles.
  • Documentation and reporting of risk-benefit analysis with the highest standard of quality in set timelines.
Risk-Benefit Analysis

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​