Non-clinical Consulting & Strategic Services

Our non-clinical consulting services portfolio encompasses tasks ranging from Regulatory query response handling to CRO qualification, ensuring global Regulatory compliance for drug product development.

Non-clinical Consulting & Strategic Services - Overview

Our Non-Clinical Consulting & Strategic Services team ensures compliant submissions by handling tasks ranging from scientific reviews and study plan development to non-clinical strategy formulation and CRO qualification consultations, making the drug product development process relatively easy. By ensuring such parameters, compliance with global Regulatory standards is assured every time.

Our services include:

  1. Scientific and Regulatory Review of Nonclinical Documents
  2. Development and Review of Study Plans/Protocols for Nonclinical Studies
  3. Nonclinical Development Strategy for Regulatory Submissions
  4. Consultation on Nonclinical Issues in the Submissions
  5. Consultation and Responses to Regulatory Queries
  6. GLP Audits of Test Facilities
  7. CRO Identification and Qualification for Nonclinical Regulatory Studies

Our services include:

  1. Scientific and Regulatory Review of Nonclinical Documents

Our nonclinical experts help ensure your submission is compliant and high-quality, supporting companies with scientific and Regulatory reviews. They verify data consistency and accuracy, helping meet deadlines and improve document quality, especially during last-minute rushes. We deliver a comprehensive review report to address concerns before submission.

  1. Development and Review of Study Plans/Protocols for Nonclinical Studies

Writing or reviewing nonclinical study plans, protocols, or reports requires expertise and understanding of the subject and Regulatory requirements. Our experienced nonclinical scientists and toxicologists can assist in preparing or reviewing these documents. Freyr’s team, with expertise in pharmacology, DMPK, and toxicology, has helped many companies ensure compliance with Regulatory standards.

  1. Nonclinical Development Strategy for Regulatory Submissions

A strong product development strategy early on is vital for success, cost reduction, and quicker approvals. Our Regulatory experts, experienced in global strategy, can help craft a solid plan with alternative strategies, such as Plan A and Plan B, based on risk. Freyr's nonclinical scientists have hands-on experience designing strategies for various innovative products, including NCEs, NBEs, 505(b)(2) products, and Biosimilars.

  1. Consultation on Nonclinical Issues in the Submissions

If you encounter development issues or have Regulatory questions related to nonclinical aspects in your submission, consult Freyr. Our non-clinical experts, with their extensive experience in the global Regulatory field, will help you find the best solution.

  1. Consultation and Responses to Regulatory Queries

If you need assistance understanding or responding to any Regulatory queries concerning the nonclinical aspects of your submission, please get in touch with Freyr. Our non-clinical experts, who have extensive experience in the global Regulatory field, will assist you in finding the best solution.

  1. GLP Audits of Test Facilities 

Looking for experts in GLP audits or inspections of test facilities for nonclinical safety studies? Consult Freyr. Our experienced nonclinical scientists and auditors can assist in CRO qualification, live study phases, or retrospective audits, either on-site or remotely. They conduct independent and unbiased GLP audits, providing comprehensive reports.

  1. CRO Identification and Qualification for Nonclinical Regulatory Studies

Are you looking to outsource your nonclinical studies to a CRO? Unsure how to pick a CRO for high-quality, compliant studies for Regulatory submission? Consult Frery. Our experienced non-clinical experts help select the right CRO by assessing quality, compliance, and capabilities for toxicology and safety pharmacology studies. We conduct unbiased evaluations using checklists and involve experts, providing a detailed assessment report and recommendations.

Non-clinical Consulting & Strategic Services

  • Highly experienced clinical and nonclinical teams led by industry leaders with decades of experience.
  • Scientists with hands-on experience in clinical and nonclinical domains.
  • Experience in handling projects from discovery to clinic stage.
  • Experience in handling complex programs involving highly innovative products and diversified therapeutic areas.
  • Strategic inputs in appropriate decision-making.
  • Experience in dealing with Regulatory authorities across the globe.
Non-clinical Consulting & Strategic Services
  • Fast turnaround time (TAT)
  • One-stop solution for clinical and nonclinical Regulatory issues.
  • Inter-disciplinary collaboration (CMC, Clinical, and Nonclinical) to ensure smooth project movement and success
  • Accessibility of experts and on-priority services
  • Customized services depending on specific needs
Non-clinical Consulting & Strategic Services

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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​