01 Claims and documentation
The documents behind your claims
Scientific dossier
We review the evidence for your ingredients and claims.
Includes
- Mechanism rationale
- Dose justification
- Safety summary
- Claims substantiation map
- Full reference list
Label and claims review
We review your label before it goes to print.
Includes
- Supplement Facts panel and ingredient statement
- Structure/function claim screen
- Disclaimer and allergen check
- Help preparing the 30-day FDA notification
- Label review memo
Testing program design
We plan the tests your product needs before its first production run.
Includes
- Test plan: identity, potency, microbiology, heavy metals and stability
- Partner lab selection
- Sample logistics
- Results review memo
Quality management support
We keep your quality files current while your product is in production.
Includes
- Supplier qualification files
- Certificate of analysis (COA) review
- Complaint and deviation support
- Change control records
- Audit preparation
02 Standards
Competent and reliable scientific evidence
We build every dossier to this Federal Trade Commission standard and state the strength of evidence for each claim.
What your brand owns
03 Clinical studies
Studies that test a claim before you make it
Clinical study design
We design a structure/function study and prepare it for Institutional Review Board (IRB) submission.
Includes
- Protocol and endpoints
- Sample size rationale
- Choice of a decentralized clinical platform or a contract research organization (CRO)
- Claims the study could support
Principal Investigator services
Brandon Sojka serves as Principal Investigator of record.
Includes
- IRB submission and correspondence
- Informed consent materials
- Oversight of conduct and data
- Adverse event review with the physician sub-investigator
- ClinicalTrials.gov registration support
- Sign-off on the final dataset
Final study report and manuscript draft
We report the results and state which marketing claims they support.
Includes
- Results of the prespecified analysis
- Claims memo
- Manuscript draft for a peer-reviewed journal
Program
Clinical Study Program
One engagement from the protocol to the final report and manuscript draft.
04 Study standards
How every study runs
- 01ProtocolPrimary endpoint and analysis set in advance
- 02IRB approvalNo enrollment before IRB approval
- 03RegistrationOn ClinicalTrials.gov before enrollment
- 04Blinded runRandomized and blinded by the platform or CRO
- 05AnalysisPrimary analysis by an independent statistician
- 01ProtocolPrimary endpoint and analysis set in advance
- 02IRB approvalNo enrollment before IRB approval
- 03RegistrationOn ClinicalTrials.gov before enrollment
- 04Blinded runRandomized and blinded by the platform or CRO
- 05AnalysisPrimary analysis by an independent statistician
- Studies with a disease endpoint declined or referred
- A physician sub-investigator on every study
- Your brand as sponsor of record and owner of the data
- Financial interests disclosed to the IRB on every study