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Your Trusted Partner for Clinical Trial Submissions
Navigating regulatory requirements for clinical trials can be complex as they vary by country, study endpoints and product classification. At SGS Nutrasource, we understand the nuances and simplify the process for you by providing end-to-end clinical regulatory services to ensure your submissions are accurate, compliant, and timely.
| With over 20 years of experience in navigating complex regulatory landscapes, SGS Nutrasource offers a full suite of clinical regulatory services to support your trial from start to finish. We specialize in Clinical Trial Applications (CTAs) for Natural Health Products (NHPs) and drugs, Investigational New Drug (IND) applications to the FDA, pre-CTA and pre-IND meeting preparation and management, ethics submissions, and lifecycle management of regulatory documents |
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Our Services:
- Regulatory Strategy and Consultation
- Pre-CTA and Pre-IND Meeting Preparation and Management
- Clinical Trial Applications (CTAs) for Natural Health Products (NHPs) and Drugs
- Investigational New Drug (IND) Applications to the FDA
- Ethics Submissions and Management
- Combination Reviews for NHPs and Drugs
- Cannabis / CBD Trial Applications and Import / Export Permits
- Learn more
Why Choose Us?
- Proven Track Record of CTA/IND Approvals : We have successfully secured Health Canada authorizations for over 160 Clinical Trials. Regulatory reviews occur on average occur within 45 business days for Natural Heath Products and within 7-30 calendar days for drugs.
- Rare Disease INDR Expertise: Our team has successfully prepared and managed IND Submissions for rare disease trials.
- Cannabis / CBD Regulatory Expertise: We support complex regulatory submissions for non-therapeutic and therapeutic research, including managing required import and export permits.
- Strong Ethical Support Background: To expedite your timeline, with an average approval of 2 weeks, we work with private ethics boards whenever possible. Experienced working with all major North American Ethics Boards for successful approval of all product classifications.