Diagnostics
The One Stop Consulting Group
IVDs Class A | B | C | D
Medical devices that analyze human specimens taken outside the body to diagnose disease, monitor health, and guide therapy. Examples of IVDs include laboratory instruments, test systems, and reagents that require FDA premarket review, ongoing regulatory oversight, and quality standards for clinical laboratories to ensure the validity of test results and patient safety
Vaccinnes
Biological products that induce immunity against diseases caused by pathogens. Vaccines must go through a thorough FDA process to ensure their safety, efficacy, purity, and potency, which includes laboratory testing, clinical trials, and facility inspections before they are licensed for use on the market. Once on the market, the vaccines are monitored for quality and safety over the entire life of the vaccines.
Companion Diagnostics (CDx)
IVDs providing key biomarker information that guides the safe and effective selection and continued monitoring of therapeutic products. CDx identify patients most likely to benefit from targeted therapies, flag those at increased risk for AEs, and help hone treatment responses. These undergo co-development with with therapies they accompany, requiring FDA approval to ensure analytical validity and consistency with approved therapeutic indications.
Our Experts
are ready to help you in:
Design Controls | Technical Documentation
Risk Management (Devices & Medicinal Products)
Human Factors & Usability Engineering
Sponsor and Contracted Performance Studies
Digital Health Devices
Diagnostics / IVDs Consulting
InVitro Diagnostic Devices
Diagnostics / IVDs Consulting
Companion Diagnostics (CDx)
Diagnostics / IVDs Consulting
FUll Service Consultancy
Customized A la Carte Service for your needs.
Precision Regulatory Consulting offers the best available first-world practical knowledge in the field of IVD from initial concept and design control through to investigational studies and ultimate worldwide approvals. They specialize in the strategy and execution of IDE studies, as well as submissions for CE Mark, 510(k), or PMA to turn complex diagnostics into audit-ready, market-cleared products ready to effectively compete in the marketplace.
RAPS and ASQ Certified
Trusted By Dozen Of Customers
“I had the pleasure of obtaining Leonel’s support at Precision Regulatory Consulting to build a blueprint based on regulatory requirements for selected jurisdictions. The level of professionalism was extraordinary. from great communication of project updates to timely project completion. I would highly recommend Precision Regulatory consulting.” – Linkedin Sr.Director QA|RA
“Leonel provided invaluable support with GxP business strategy and guidance for successful development and Ph3 trial support of a combination product…He delivered on every milestone and more. His passion for developing others was evident in some key training that he designed and delivered: training on design controls, human factors, risk management, and US/CAN/EU MDR evolving regulations.” Linkedin VP Global Head of R&D Quality
“I worked with Leonel for a year on an Autoinjector program. Leonel is a proactive Quality leader. He provides solid guidance on how to comply with Regs and SOPs, while also being pragmatic to ensure the work is done correctly and on schedule. Leonel provides overviews of his expectations prior to work starting. This provides project teams a clear path for quality deliverables.” Linkedin Director – Autoinjector Platform Lead
Phone
(984)328-3028
Location
Raleigh, NC
precisionregulatoryonline@gmail.com
Store Hours
M-F: 8am – 8pm
S-S: 9am – 12pm