Non-clinical Consulting & Strategic Services

Our non-clinical expert team handles tasks from regulatory query responses to GLP audits and CRO qualification, ensuring global Regulatory compliance for drug product development.

Non-clinical Consulting & Strategic Services - Overview

Our non-clinical consultation team ensures compliant submissions by handling tasks right from scientific reviews, study plan development, and non-clinical strategy formulation to CRO qualification consultations that pave a relatively easy endeavor for drug product development. By ensuring such parameters, compliance with global Regulatory standards is certain 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

No matter if it’s writing nonclinical documents or reviews, our nonclinical experts can help you to make sure that your submission is fully compliant and of the highest quality. At Freyr, we help numerous companies with scientific and Regulatory reviews of their dossiers. Meeting the deadlines and last-minute rush sometimes lead to errors and mistakes in the documents. Therefore, third-party reviews often help overcome such issues in the Regulatory documents. Our non-clinical experts ensure that the data and information are consistent across the documents and true reflection of the primary source documents. Our dedicated resources with a fast turnaround time ensure that you do not miss the deadline for submission. In the end, we provide a comprehensive review report to help you address all the identified concerns before Regulatory submission.  

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

Writing or review of nonclinical study plans/protocols or study reports requires expertise and an in-depth understanding of the subject and Regulatory requirements. Our highly educated and well-experienced nonclinical scientists and toxicologists can help you in writing or reviewing study plans/protocols and study reports for any kind of nonclinical study. Freyr’s nonclinical team with experts from pharmacology, DMPK, and toxicology have helped numerous companies write or review the study plans/protocols or study reports in compliance with current Regulatory requirements.

  1. Nonclinical Development Strategy for Regulatory Submissions

A robust product development strategy for your innovative compound at the earliest stage is crucial not only for successful submission and/or approval but also to save on cost and timeline significantly. To achieve this goal, our Regulatory experts with their vast experience in global Regulatory strategy can help you prepare a robust development plan with necessary alternate strategies (Plan A, Plan B, etc) depending on the perceived risk. Nonclinical scientists at Freyr have hands-on experience in developing and designing a nonclinical strategy for a variety of innovative product categories including NCEs, NBEs, 505(b2), and Biosimilars.     

  1. Consultation on Nonclinical Issues in the Submissions

If you are stuck with development issues or any Regulatory queries related to nonclinical aspects in your submission, consult Freyr. Our non-clinical experts with their vast experience in the global Regulatory domain would help you with the appropriate solution.

  1. Consultation and Responses to Regulatory Queries

Need help in understanding or responding to any Regulatory queries related to nonclinical aspects of your submission, please consult Freyr. Our non-clinical experts with their vast experience in the global Regulatory domain would help you with the appropriate solution.

  1. GLP Audits of Test Facilities 

Looking for experts for GLP inspection or audits of test facilities conducting nonclinical safety studies on your product, consult Freyr. Our nonclinical scientists and auditors with hands-on experience in GLP working environments for several years can help you. GLP inspection as part of CRO qualification or live phase of the nonclinical study or retrospective audits at the site or remotely, we have experience in all of these activities. Our technical experts and auditors can perform an independent and unbiased GLP audit of test facilities and provide you with a comprehensive audit report.

  1. CRO Identification and Qualification for Nonclinical Regulatory Studies

Are you looking to outsource your nonclinical studies to CRO? Are not uncertain about how to pick a CRO to conduct of high-quality and compliant studies for Regulatory submission? Consult Frery. Our non-clinical experts with several years of hands-on experience in the conduct of GLP-compliant nonclinical studies can help you choose the most appropriate CRO. Our experts have performed CRO identification and qualifications based on quality, compliance, and technical capabilities for the conduct of Regulatory toxicology and safety pharmacology studies for several companies. We perform an independent and unbiased evaluation of CRO to determine its suitability for conducting the studies for Regulatory submissions. We involve relevant experts and follow the checklists to evaluate CROs on multiple parameters. At the end, we provide a comprehensive assessment report with our 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

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​