Clinical Services

At Freyr, our tailored clinical writing ensures clear, Regulatory-compliant documents for smooth submissions and approvals. With comprehensive clinical trial documentation, strategic consulting, and effective communication, we help you with the dynamic regulations and achieve your goals.

Clinical Services - Overview

Our clinical writing solutions address the complex requirements of clinical documentation across various stages of drug product development. These solutions encompass the creation of clear, accurate, and Regulatory-compliant documents for successful Regulatory submissions, facilitating seamless medicinal product approvals.

Our clinical writing services range from clinical trial documentation preparation to assisting valued clients through expertise and best compliance practices. We ensure that all documents comply with global Regulatory standards and conform to local Regulatory requirements.

We ensure our clinical services meet clients' specific needs and provide them with ongoing project-related support and assistance to navigate the Regulatory landscape and achieve successful product development and approval.

Our services include:

  • Regulatory Medical Writing Services
  • Clinical Trial and Consulting Services
  • Clinical Trial Audit and Monitoring Services

Clinical Services

  • Patient-centric approach
  • Expert compliance assurance
  • Regulatory strategy consulting
  • Risk assessment and mitigation
  • Comprehensive clinical trial documentation
  • Compliant creation of layperson summaries
  • Crafting effective scientific communications
  • Upholding best practices in data transparency and disclosure
  • Efficient Regulatory submissions

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​