Nonclinical toxicology, strategic planning, and scientific writing services supporting the pharmaceutical product development process.
Client Feedback:
• Excellent job on Module 2.6.4 • Thank you so much for all your ongoing support. The partnership and collaboration with you and the Intertek team offers tremendous reassurance to us. An amazing end to the week! • This is great news, arriving at the right time for the company • Thank you so much for your timely and considered response. You are always so thorough, that you leave me with me little to ask in follow up! • Thank you and your team in delivering a great document that was reviewed by ex-FDA pharmacologist. What a way to verify the process, she found little to comment on from your excellent work. As always it is a pleasure to work with your group • Thank you so much Assuris for helping us getting this far already, we have very much enjoyed working with you all at Intertek, as always. We are confident the work done so far will prove useful to ourselves or any potential partner and we’ll reach out as soon as there are any update to share • We really appreciate Intertek’s great work on organizing the PIND and the IND for our projects.
In the complex world of pharmaceutical product development, companies often encounter numerous challenges. Success comes from establishing a comprehensive strategy that meets regulatory expectations and company goals. The various regulatory requirements in different countries can be confusing, requiring expert help to implement effective strategies. It is crucial for a company to demonstrate sufficient knowledge and understanding of the product’s safety, together with effectiveness and quality, to support clinical development. Efficient and well managed nonclinical programs with thorough and strategically positioned regulatory documents (e.g., INDs, NDA/BLA, CTAs, Investigator’s Brochure) are essential for securing regulatory approvals and advancing drugs to market. By integrating these elements, companies can bridge the gap between scientific innovation and regulatory success, ensuring safe and innovative treatments reach patients efficiently.
Intertek’s Pharmaceutical and Healthcare Consulting Group is a leading worldwide consulting services provider in the pharmaceutical and biotechnology industry. We provide expert toxicology and drug development services through a team, including Board-certified toxicologists, with extensive hands-on industry experience.
Our innovative solutions address complex product development, toxicological, and safety issues across various therapeutic modalities (small molecules, biologics, ADC/PDCs, drug combination-medical devices, etc.) and indications (neurological, neurodegenerative, cardiovascular, endocrine, metabolic, oncology, wound healing, etc.). Working together with our clients and our own regulatory affairs team, we deliver high-quality drug development and regulatory solutions with precision, pace, and passion, enabling safe and effective product advancement.
Our goal is to work and collaborate with clients to support their project’s success from conception through to market approval and beyond. We provide expert advice on multiple aspects of product development programs, specializing in:
Toxicology Consulting
- Feasibility, gap analysis, and due diligence activities
- Interpretation and positioning of data
- Scientific issue resolution
- Risk and safety assessments
- Liaison with regulatory agencies worldwide
- Research and white paper development
Strategic Planning
- Innovative strategies for successful product development
- Cost effective drug development planning
- Integration of nonclinical programs with CMC and clinical development
- Anticipation and resolution of regulatory hurdles (e.g., FDA, Health Canada, MHRA, EMA, TGA)
Drug Development
- Nonclinical program management
- Study oversight and monitoring
- Real-time data review and issue resolution
- Dossier authoring and preparation (e.g., IB, IND, NDA, BLA, DSUR, CTA, NDS)
- Clinical and CMC advice and support
Regulatory Affairs
- US & Canada Regulatory & Product Strategies
- Product Classification & Lifecycle Support
- INDs, CTAs, BLAs, NDAs, DMFs & More
- Regulatory Agency Interactions & Negotiations
- CMC Regulatory Writing & Support
- Non-prescription Drugs, Cosmetics & Disinfectants Marketing Support
Additional specialized expert support for product development includes:
