Non-Clinical Services

Freyr specializes in comprehensive non-clinical Regulatory writing services with a dedicated team of non-clinical experts who ensure compliance with the latest Regulatory requirements. They deliver high-quality documents from pre-IND/CTA meeting requests to complex Regulatory processes by ensuring quality and timely submissions.

Non-Clinical Services - Overview

Non-clinical modules/documents are essential components of any Regulatory submissions for pharmaceuticals. Some of the critical Regulatory decisions are based on non-clinical aspects of pharmaceutical development and the logical presentation of the information in the Regulatory submissions. Therefore, the quality of non-clinical documents and modules in any Regulatory submission must be of the highest standard to ensure success.

As an expert and trustworthy Regulatory partner, our non-clinical team has played a pivotal role in facilitating high-quality non-clinical writing for numerous Regulatory submissions. Our team is involved right from the beginning of any development program by contributing to strategic decision-making and designing a robust non-clinical development plan most appropriate to the type of your product. Our experienced and qualified scientists, non-clinical experts, and toxicologists ensure that your non-clinical documents are developed in full compliance with applicable Regulatory guidelines and submission-specific requirements.

Our non-clinical experts have supported numerous programs encompassing a variety of submissions through pre-IND/CTA to NDA/BLA/MAA for novel pharmaceuticals (NCE/NME or NBE) or repurposing of already approved drug products (505(b)(2) or hybrid).

A general list (but not limited to) of non-clinical Regulatory writing services offered by Freyr is as follows:

  • Non-clinical overview and summaries
  • Non-clinical sections of the meeting packages
  • Non-clinical sections of Investigator's Brochure (IB)
  • Weight-of-Evidence (WOE) assessment for carcinogenicity
  • Special Protocol Assessment (SPA) for carcinogenicity
  • Abuse liability assessment

Non-Clinical Services

  • Project planning and on-time delivery of documents, including priority submissions
  • Non-clinical scientists with hands-on experience in conducting various non-clinical studies (pharmacology, DMPK, and toxicology) as study directors, study personnel, QA, or pathologists
  • Well-established systems and processes from initial planning to final submission
  • Quality check and multiple checkpoints to ensure accurate and reliable data in the submission
  • Expert review by highly experienced non-clinical experts
  • Well-qualified and highly experienced nonclinical experts, including board-certified toxicologists (DABT and ERT) and pathologists
  • Experience in handling complex programs involving highly innovative products
  • Strategic inputs in appropriate decision-making

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​