Tailoring and Designing Effective Non-Clinical Development Program
Effective Regulatory strategy planning is an important aspect of any discovery program. The planning and designing of a scientifically robust non-clinical development plan tailored to the specific requirements of the project is of utmost importance in the successful filing of IND and further developments including the NDA submission. Our team of toxicologists, with several years of experience in the field of drug development, has supported numerous small and mid-sized pharma/biotech companies at various stages of drug development as a strategic partner. The non-clinical development programs and strategies proposed by our experts have been well accepted by various Agencies including the US FDA. The programs comprised of innovative small and large molecules including NDA submissions for new indications and alternate route of delivery.
Planning and Designing Non-clinical Proof of Concept (PoC) Studies
Depending on the type of project and therapeutic area (for example, inflammation and autoimmune diseases, CNS, metabolism, wound management including infectious diseases, etc.), our Regulatory affairs consultants have helped clients in the selection of relevant animal models for understanding the non-clinical Proof of Concept (PoC), including pharmacokinetic aspects. Our experts can help in planning and designing of non-clinical PoC studies to suit clients’ specific program requirements.
Planning and Designing Early Discovery Pharmacology and Toxicology Studies
Planning of scientifically robust and appropriate early discovery studies and clinical research studies to enable selection of better candidates for further development is not only important for resource conservation but also helps save time and unnecessary spending on nonviable drug candidates. Our experts can assist in the selection of right candidate(s) and appropriate decision-making process. Early discovery studies designed to answer specific questions with minimal resources and quick turnaround time are important in this process. Similarly, proper scientific evaluation of preliminary results at an early stage is essential in prioritization of the development.
Strategic Support including Designing of Regulatory (GLP) Toxicology Studies for IND/BLA/NDA Submissions
As per the requirement of the program, deciding on the more scientifically appropriate and pivotal non-clinical studies for various Regulatory filings such as IND/BLA and NDA type of submissions is crucial. Proper planning, designing, and conduct of the important studies at the initial or early stage of development is essential for on-time submissions and approvals. Our experts, with their vast experience, can help identify the required non-clinical studies and assist in designing the studies for Regulatory submissions.
Development of Strategy and Material for Pre-IND Meeting and Briefing Packages
Preparation of the pre-IND briefing document is the first and important milestone in the Regulatory strategy development process. It is an opportunity to express the drug development plan and seek the Agencies opinion/concerns at the beginning itself to avoid any Regulatory issues later in the product development process. Depending on the program, preparation of a comprehensive briefing package and seeking clarity or asking questions/queries in an appropriate manner prior to pre-IND meeting is highly essential to avoid any ambiguities at a later stage. Our Regulatory experts from diverse backgrounds (CMC, Non-clinical, and Clinical) have worked on numerous projects and developed briefing books, clinical development plans, and pre-IND meeting packages for a variety of programs. On occasion, strategic questions with proper scientific background provided by our Regulatory affairs consultants have helped clients in getting waivers for certain non-clinical and clinical studies, thereby saving on cost and development/approval timelines.
Evaluation and Qualification of CRO for Conduct of Regulatory Toxicology Studies
Identification, qualification, and selection of Contract Research Organization (CRO) for conduction of GLP toxicology studies with good experience in high-quality data management and scientific capabilities to handle non-clinical studies is crucial for any discovery program. Our experts, with years of actual experience in the GLP work environment, can help identify and qualify the most appropriate CRO for conducting non-clinical studies based on the type of program.
Review and Monitoring of Non-clinical Studies at CROs
Once the CRO is selected, it’s time to kick start the activities for conduction of GLP studies. Right from the initial stage i.e., drafting or review of study plans for non-clinical studies, review, and evaluation of interim data, and monitoring the progress of the study, it is significant to avoid any unforeseen situations at the end. Our global Regulatory strategy experts have developed and/or reviewed study plans for a variety of non-clinical studies and provided their invaluable inputs at the right time. Our experts have also monitored the progress of non-clinical studies by on-site or off-site inspections to complete the projects effectively and successfully.
Development and Review of Clinical Study Protocol
The Medical Writing and Clinical teams at Freyr have expertise and experience in clinical development plans and review of clinical study protocols. The teams are involved in developing a variety of protocols for different scopes or objectives of the studies including, but not limited to, SAD, MAD, proof of concept, pharmacokinetic, pharmacodynamic, human abuse liability studies, and regular efficacy and safety studies. Our Regulatory strategy team has myriad experts including pharmacologists, medical professionals, pharm D professionals, medical writers, and statisticians.
Freyr Clinical Advantages
- In-depth Regulatory knowledge. Our Regulatory affairs consultants are perfectly integrated with IT capabilities.
- Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars.
- Clinical development plans.
- Vast experience in working across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Defined processes of thorough scientific, medical, editorial, and quality control review inhouse, prior to the sponsor review.
- Experience in writing documents for various phases of clinical development including Phase I to Phase IV, Post-Marketing Surveillance Studies (PMS) and Post-Authorization Safety Studies (PASS).
- Well-versed in working with various stakeholders like clinical operations, data management, biostatistics, medical, and safety teams to deliver documents.
- Submission-ready documents in terms of technical information, language, format, and template used to prepare the document.
- Timely delivery with the highest standard of quality.
Freyr Non-clinical Advantages
- Qualified, trained, and experienced team of toxicologists and data scientists with in-depth understanding of non-clinical requirements for various submissions involving diverse discovery projects.
- Experienced in the designing of non-clinical development plans for complex projects including identification of potential risk and mitigation strategy in the context of overall Regulatory strategy.
- Good knowledge and understanding of toxicological risk assessments of excipients and impurities including defining the qualification limits.
- Freyr has staff with first-hand experience in working in the GLP environment as study director and also those who have a fair understanding of manufacturing process and Good Manufacturing Practice (GMP) requirements.
- Robust quality control system for drafting and reviewing non-clinical and toxicology safety assessment reports, which assure scientifically correct and audit/submission ready documents.
- Freyr has an expert team that can deliver documents faster than the standard time taken by others in the industry for the same task.
- Qualified and experienced team of experts.
- Cost-effective services with faster turnaround time.
- On-time and priority deliveries depending on the urgency.
- Help/assistance on Regulatory queries addressal.