The development of a pharmaceutical drug is a complex, multifaceted process requiring the highest level of strategic planning and project management from beginning to end. Our experienced regulatory team can partner with you to design and implement a drug development strategy that will ensure compliance with Health Canada and U.S. FDA requirements for prescription drugs.
Nutrasource is uniquely positioned between the nutraceutical and pharmaceutical industries, bringing expertise and experience from both market segments to provide superior value and high-quality outcomes for our clients. Our “pharma-lite” product development strategy allows your firm to maximize time-to-market while optimizing your R&D budget.
We help guide Sponsors in understanding and complying with the various regulatory requirements to ensure your pharmaceutical is properly positioned. We also offer dietary supplement to drug strategy consulting to explore the pharmaceutical potential of natural products and navigate the complexities and differences between the two pathways.
Explore our regulatory and clinical services for pharmaceuticals:
- Product Development Strategy
- Clinical Trials
- Drug Establishment Licensing
- New Drug Submissions (NDS) and New Drug Applications (NDA)
- Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
- Clinical Project Management
- Clinical Trial Design
- Regulatory Affairs
- Early Clinical Development
- Phase II/III Clinical Trials
- Phase IV Clinical Trials
- Rescue Studies
- Feasibility Studies
- Site Selection and Management
- Medical Affairs and Pharmacovigilance
- Data Management
- Functional Services
- On-Site Clinical Trial Services
Our product testing services for pharmaceuticals include:
Learn how we can help you design a pharmaceutical development plan that delivers results.
Case Study: A Multi-Centre Clinical Trial to Determine the Efficacy of an Omega-3 Medical Food in NAFLD
Learn how we helped one Sponsor gain market entry for a medical food with a unique health claim.
How Health Canada’s Upcoming Self-Care Product Regulations Could Impact Your Marketed Natural Health Products, Non-Prescription Drugs, and Cosmetics
New self-care product regulations are coming to Canada. Will your brand be ready?