21 CFR Part 11

ATUSA, LLC (branded Alpha Tech USA) is a team of professionals with over 40 years combined experience assisting FDA-regulated companies with full life cycle validation services. They offer validation services for manufacturing and packaging equipment, with main expertise in pharmaceutical inspection systems for particle and cosmetic defects, and they fabricate cosmetic and particulate test standards (defect sample sets or control sets).

cleaning validationcomputer systems validationfabrication of test standardsfacilities design consultingFactory Acceptance Testsfull life cycle validationInstallation, Operation, and Performance QualificationKnapp Statistical StudySite Acceptance Testsvalidation services

cGMP Validation was established in 1997 as a full service validation/compliance firm serving the pharmaceutical, bulk pharmaceutical, animal health, biotechnology, biologics, medical device and medical diagnostic industries. It specializes in preparation and execution of validation IQ/OQ/PQ protocols and compliance documentation for equipment, utilities, processes, laboratory instruments, and computer systems, with clients across the US, Puerto Rico, Canada and internationally.

Auditingcommissioningcompliance consultingComputer System Validationdocument preparationfactory acceptance testingqualificationrisk assessmentsite acceptance testingtrainingvalidation

Dawes Fretzin Clinical Research is a clinical research group specializing in dermatology with 24 years of clinical trial experience and 500 total clinical trials as of February 2024. The group has primary investigators Scott Fretzin, MD, Kenneth Dawes, MD, and Michael Sheehan, MD, along with 13 sub-investigators, 8 study coordinators, and 1 regulatory coordinator. It conducts Phase I-IV trials as well as pharmacokinetic, pharmacodynamic, and bioavailability/bioequivalence studies.

CITIclinical trialsElectronic Data Capture (EDC)GCPHIPAAIATAInformed Consentpatient enrollmentSAE Reporting