Clinical Writing Consulting and Strategic Services

Our comprehensive clinical development services merge operational, medical, and Regulatory expertise to expedite drug product development and approval. We ensure high-quality and timely project completion alongside regulatory compliance for our clientele.

Clinical Writing Consulting and Strategic Services - Overview

Clinical development is becoming more difficult and complex from an operational, scientific, and Regulatory standpoint. Our full-service model, which combines operational, medical, and Regulatory expertise, provides our clients with one integrated solution, expediting the development and approval of their medicinal products.

Our Clinical team works in collaboration with the sponsors for their clinical development plan, clinical strategies, and clinical outcomes offering strategic thinking to guarantee timely project delivery, excellent quality, and the most effective completion of each stage of their clinical projects.

Every collaboration is planned to produce effective solutions that are focused on market needs and requirements. Our therapeutic and Regulatory expertise is dedicated to serving an expediting route for approval.

We provide end-to-end clinical strategy and consultation solutions at each stage of drug development that are in line with various country-specific Regulatory requirements and guidelines.

Our consultation services include:

  • Consultation advice on pre-IND/ IND/ NDA document dossiers
  • Response to Health Authority Queries
  • Development of Clinical strategy for meeting Packages/ Briefing Books
  • Development of Clinical Study Plans
  • Justification documents
  • Clinical Study Design strategies specific to Therapeutic area requirements

Clinical Writing Consulting and Strategic Services

  • Integrated solutions with end-to-end knowledge in operations, medical, and Regulatory requirements
  • End-to-end clinical strategy and guidance in all phases of drug development
  • Strategic collaboration with sponsors for clinical development plans and outcomes
  • Expertise in developing clinical study designs tailored to therapeutic areas
  • Comprehensive understanding of country-specific Regulatory requirements and guidelines
  • Consultation on pre-IND/ IND/ NDA documents dossiers and answering responses to health authority’s queries
  • Development of clinical strategies for Regulatory meeting packages and briefing books
  • Closely coordinates with sponsors to guarantee prompt project completion and excellent results
  • Offers strategic thinking to successfully finish clinical projects at every stage
Clinical Writing Consulting and Strategic Services
  • Provides one integrated solution that streamlines the development and approval process
  • Combined operation, medical, and Regulatory expertise for efficient project execution
  • Collaborates closely with sponsors to ensure timely project delivery and high-quality outcomes
  • Provides strategic thinking to effectively complete each stage of clinical projects
  • Provides consultation services aligned with various Regulatory requirements and guidelines
  • Provides effective and efficient development processes for medicinal products, tailored to market needs and Regulatory requirements
  • Expertise in clinical study design specific to therapeutic area requirements
  • Provides justification documents to support clinical strategies
Clinical Writing Consulting and 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​