Non-clinical Services

Freyr specializes in comprehensive nonclinical regulatory writing services, essential for robust pharmaceutical submissions. Our team of experts ensures compliance with Regulatory guidelines, delivering high-quality documents from nonclinical overviews to study protocols.

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Non-clinical Services - Overview

Nonclinical modules/documents are essential components of any regulatory submissions for pharmaceuticals. Some of the critical regulatory decisions are based on nonclinical aspects of the pharmaceutical development programs. Therefore, the quality of nonclinical documents/modules in any regulatory submission must be of the highest standard to ensure the success of your regulatory submissions.

As a trustworthy regulatory partner, our non-clinical expertise plays a pivotal role in facilitating high-quality nonclinical writing for any kind of regulatory submission. We impart our strategic role right from the beginning of any development program by contributing to strategic decision-making and designing a robust nonclinical development plan for your product. Our highly experienced and qualified scientists, non-clinical experts, or toxicologists ensure that your nonclinical documents are in full compliance with applicable regulatory guidelines and submission-specific requirements to ensure that your submission meets the highest standard.

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 (505b2 or hybrid). A general list of nonclinical regulatory writing services offered by Freyr is as follows:

  • Writing of Nonclinical Overview and Summaries (300 to 500 words) (this will also highlight our experience and expertise)
  • Writing of Nonclinical Sections in the Meeting Packages (300 to 500 words)
  • Writing of Nonclinical Sections in the Investigator's Brochure (IB) (300 to 500 words)
  • Writing of Weight of Evidence (WoE) for Carcinogenicity
  • Writing of Special Protocol Assessment (SPA) for Carcinogenicity
  • Abuse Liability Assessment
  • Scientific and Regulatory Review of Nonclinical Documents
  • Development and Review of Study Plans/Protocols for Nonclinical Studies

Non-clinical Services

  • Project planning and on-time delivery of documents, including priority submissions.
  • Nonclinical scientists with hands-on experience in conducting various nonclinical 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 nonclinical 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.

Partnering with Leading Organizations

 

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

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

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​