A sound regulatory strategy provides a foundation for successful healthcare innovation. This is particularly relevant for diagnostics companies that develop highly sophisticated diagnostics products, that face increased regulatory oversight of ASRs and IVDMIAs, or that deal with evolving regulation of home-brew tests and CLIA labs.
Beaufort, LLC, is an IVD CRO that helps develop and implement customized regulatory strategies designed to optimize the development of in vitro diagnostics products. Our FDA regulatory consulting services include preparing the overall product development plan, creating a customized regulatory strategy and submission of 510(k)s.
IVD companies in the U.S. and in countries such as Canada, United Kingdom, Germany, France, Italy, Netherlands, China, Japan, South Africa, Brazil, Venezuela, Israel, and Kuwait trust Beaufort with their regulatory submissions.
In Vitro Diagnostics Regulatory Consulting Services
FDA regulatory consulting for U.S. clients and a host of IVD regulatory services for clients around the world include:
- Regulatory strategies
- Device classification
- Predicate device identification
- Pre-IDE submissions and meetings (scheduling, information package development, presentation assistance, and FDA mediation)
- Protocol and study design development
- 510(k) submissions
- De Novo submissions
- PMA and PMA supplement submissions
- IDE applications
- Device master files
- FDA 483 letter responses
- Warning letter resolution
- Liaise with FDA and European authorized representatives
- CE marking
- Post-market support
- Regulatory training
For each type of IVD submission Beaufort can provide statistical support including the development of statistical analysis plans (SAP) and sample size rationales, performing the analysis outlined in the SAP, and interpretation of the statistical results.
In Vitro Diagnostics Experience
Beaufort has IVD regulatory experience in the following diagnostic areas:
Types of Assays
- ASRs
- Biomarkers
- CLIA Waived Tests
- Combination Products
- Companion Diagnostics
- Drug-of-Abuse Assays
- Genetic Testing
- High Throughput Testing
- IVDMIA
- LDTs
- Molecular Diagnostics
- POC Testing
- Proteomics
Technology Expertise
- PCR, Real Time PCR, Reverse Transcriptase PCR
- MicroRNA and siRNA Detection
- DNA and RNA Expression Assays
- Immunoassays
- Immunohistochemistry
- Microarrays
- Electrochemiluminescence
- ELISA
- FISH and SKY
- Controls and Calibrators
Intended Uses
- Screening
- Prognostic
- Theranostic
- Diagnostic
- Monitoring
- CLIA Laboratory
- CLIA waiver
Therapeutic Expertise
- Cardiology
- Clinical Chemistry
- Endocrinology
- Genetic Disorders/Diseases
- Hematology
- Immunology
- Infectious Diseases
- Obstetrics/Gynecology
- Oncology
- Opthalmology
- Orthopedics
- Respiratory
- Toxicology
