Clinical and Non-Clinical Consulting and Strategic Services

Our personalized consultation and strategy ensure accurate and timely Regulatory submissions. Thorough reviews by our expert teams also involve robust strategy creation and detailed evaluations, ensuring compliance and quality. With quick turnaround time and tailored support, we efficiently meet all your Regulatory needs.

Clinical and Non-Clinical Consulting and Strategic Services- Overview

Our experienced team at Freyr assists with scientific and Regulatory reviews, ensuring consistency and accuracy across all documents to meet tight deadlines without errors. We provide thorough review reports to address any concerns before submission.

Our experts and toxicologists undertake reviews of study plans, protocols, and reports, ensuring they meet current Regulatory requirements. We help you curate robust development strategies with alternate plans to mitigate risks, ensuring cost and time efficiency for innovative product categories, including NCEs, NBEs, 505(b)(2), and biosimilars.

Considering GLP audits, our experienced scientists and auditors conduct independent evaluations of test facilities, ensuring compliance and providing comprehensive audit reports. Freyr's non-clinical services are designed to support your Regulatory submissions, facilitating successful product development and approval.

Our services ranges are:

Clinical writing consulting and strategic services
Technical writing support for GXP compliance
Business process optimization
Scientific and Regulatory review of non-clinical documents
Development and review of study plans and protocols
Non-Clinical development strategy
Consultation on non-clinical issues
Consultation and responses to Regulatory queries
GLP audits of test facilities
CRO identification and qualification

Freyr’s Clinical and Non-Clinical Consulting and Strategic Services

Clinical and Non-Clinical Consulting and Strategic Services

Expertise
Advantages

Highly experienced clinical and non-clinical teams led by industry leaders with decades of experience
Scientists with hands-on experience in clinical and non-clinical domains
Experience in handling projects from discovery to the clinical 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’ queries globally

Fast turnaround time
One-stop solution for clinical and non-clinical Regulatory issues
Inter-disciplinary collaboration (CMC, clinical, and non-clinical) to ensure smooth project movement and success
Accessibility of experts and on-priority services
Customized services depending on specific needs

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

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

Global CMC Technical Lead
China-based, Leading Innovator Pharmaceutical Company

Medicinal Products

Medical Writing

USA

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

What’s New?

What is Medical Writing

Tailoring Regulatory Medical Writing for Different Audiences: Patients, Clinicians, and Regulators

Blogs

March 26, 2025

Medical Writing

Tailoring Regulatory Medical Writing for Different Audiences: Patients, Clinicians, and Regulators

Medicinal Products Regulatory Services

Medical Devices Regulatory Services

Consumers

Freyr Digital

Stay Ahead of the Curve With Our Innovative Regulatory Software Solutions

Clinical and Non-Clinical Consulting and Strategic Services

Clinical and Non-Clinical Consulting and Strategic Services- Overview

Freyr’s Clinical and Non-Clinical Consulting and Strategic Services

Clinical and Non-Clinical Consulting and Strategic Services

Celebrating Customers Success

SVP - R&D ( Finished Dosage Form)
US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development

Head of Quality Assurance

Head of Quality Assurance
India-based, Leading Pharma Contract Manufacturing Organization

Global CMC Technical Lead
China-based, Leading Innovator Pharmaceutical Company

Director, Global Labeling Management – Labeling Cluster Head Global Product Development, Global Regulatory Affairs
US-based, Multinational Pharmaceutical and Biotechnology Company

Lead, R&D/Personal Care
India-based, Multinational Consumer Goods Company

SVP - R&D ( Finished Dosage Form)
US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development

Head of Quality Assurance

Head of Quality Assurance
India-based, Leading Pharma Contract Manufacturing Organization

Global CMC Technical Lead
China-based, Leading Innovator Pharmaceutical Company

Director, Global Labeling Management – Labeling Cluster Head Global Product Development, Global Regulatory Affairs
US-based, Multinational Pharmaceutical and Biotechnology Company

Lead, R&D/Personal Care
India-based, Multinational Consumer Goods Company

SVP - R&D ( Finished Dosage Form)
US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development

What’s New?

How can we help you?

Please let us know your requirements, and we will contact you.