Freyr as a Partner from Discovery Stage - Overview
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.
Freyr as a Partner from Discovery Stage
- 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.
- 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.
