Clinical and Regulatory Support for
CEBIS supports nutraceutical, dietary supplement and food-for-special-medical-purpose programs with clinical study coordination, safety and efficacy evidence generation, regulatory support and related development activities.
Support can be aligned to the product, intended claims, target markets and evidence requirements.
Evidence and Regulatory
Product & Evidence Planning
Understand the product, intended use and type of evidence required.
Clinical Study Design
Define an appropriate study approach where clinical evidence is needed.
Safety & Efficacy Research
Generate relevant clinical evidence based on the product and study objectives.
Data & Statistical Analysis
Collect, review and analyze study information.
Regulatory Support
Align product documentation, labeling, claims and other requirements with the target market.
Generating Evidence for
Study Planning
Define the clinical question and evidence objectives.
Protocol Development
Prepare an appropriate study design based on the product and target outcomes.
Clinical Execution
Coordinate sites, participants and study activities.
Data & Statistics
Collect and evaluate study results.
Reporting
Organize results into appropriate study documentation.
Clinical Evidence Connected to
Support can include:
Navigating Product Requirements Across Markets
Product Classification & Registration
Support understanding the applicable product category and registration requirements.
Formulation & Conformity Review
Review the formulation in relation to applicable requirements.
Labeling Review
Review labels and packaging against relevant market requirements.
Nutrition & Health Claims
Support review of proposed claims and their evidentiary basis.
Advertising & Marketing Review
Review applicable regulatory considerations around promotional materials.
Novel Food Support
Support relevant documentation where a novel-food pathway applies.
Nutraceutical Studies Use the Same Core Study Discipline
Relevant services can include:
- Clinical Trial & Project Management
- Site Management & Monitoring
- Patient Recruitment
- Data Management
- Biostatistics
- Medical Writing
- Regulatory Affairs
- Quality Oversight
Build the Program Around
Planning considerations include:
Product Category
What type of product is being developed?
Target Markets
Where does the organization intend to commercialize it?
Intended Claims
What benefit or use does the company want to communicate?
Existing Evidence
What scientific or clinical evidence already exists?
Evidence Gaps
What additional work may be necessary?
Developing a Nutraceutical or FSMP Product?
Tell us about the product, target market, intended claims, existing evidence and clinical or regulatory support you need.