AndroMed, LLC

AndroMed, LLC provides scientifically based and experience-driven consulting services for Assisted Reproductive Technology (ART) laboratories. Services we offer to support your andrology, endocrinology, and embryology laboratories include, but are not limited to: ✅CAP, CLIA, and FDA application processing for accreditation ✅CAP, CLIA, and FDA regulatory compliance and mock inspections ✅Evaluation of regulatory citations, letters, and responses ✅FDA Donor Eligibility Determinations for egg and sperm donors ✅Health Canada Donor Suitability Assessments for egg and sperm donors ✅Laboratory design and set-up ✅SOP development and improvement ✅QA, QC, and QM program audits ✅QC documentation review and improvement ✅KPI data collection and analysis ✅Cryo inventory management ✅Cryo inventory risk-reduction strategies ✅Personnel training and retention ✅Per diem laboratory technician coverage ✅Per diem on-site Technical Supervisor coverage ✅Off-site Technical Supervisor support ✅Anonymous and directed donor processing for sperm, eggs, and embryos ✅In person, hands-on training sessions in your own laboratory ✅General laboratory consulting and advising ✅...and much more! In addition, AndroMed also offers services to support the academic and research industries, including: ✅Advisor and Committee roles for project development ✅University lectures on human reproduction and IVF ✅Medical device validation studies ✅Reproductive research design and methodology ✅Manuscript review and editing ✅...and much more! Your consultant will have over a decade of experience in ART laboratories, will be double board-certified as both a Technical Supervisor by the American Board of Bioanalysis and a Certified Laboratory Consultant by the American Medical Technologists, and also an active CAP inspector. Contact us today! We will develop customized solutions tailored to your unique needs.