AltaQ

AltaQ is a regulatory and quality compliance consultancy serving in vitro diagnostics (IVD), laboratory developed tests (LDT), medical device, and pharmaceutical companies. Based in Bethesda, Maryland, the firm provides regulatory affairs, quality assurance, and clinical validation services to support FDA submissions, international regulatory requirements, and laboratory accreditations.

The team offers end-to-end support for FDA pathways including 510(k), de novo 510(k), PMA, and IDE submissions, as well as EU IVDR/MDR compliance. Their quality systems expertise encompasses FDA QMSR, ISO 13485, and CLIA/CAP standards, with additional capabilities in analytical, software, process, and facility validations. AltaQ has supported clients across the United States, Europe, Japan, South Asia, China, and Australia.

The firm has over 30 years of collective experience in the diagnostic and medical device sectors, with a team of 10+ qualified experts. Their client retention rate is reported at 100%, and they maintain specific expertise in companion diagnostics and FDA pre-approval inspections.

Choose AltaQ when navigating complex FDA submission pathways or requiring specialized expertise in IVD/LDT regulatory strategy. The firm's integrated approach to regulatory, quality, and clinical affairs can streamline compliance efforts for organizations seeking cohesive program management across multiple regulatory domains.

Expect hands-on consulting from experienced professionals who understand both domestic FDA requirements and international regulatory frameworks. The firm offers free initial assessments and appears positioned to serve as an extension of internal regulatory teams for companies lacking dedicated compliance resources.

AltaQ operates exclusively within the life sciences healthcare sector, concentrating on three primary verticals: in vitro diagnostics and laboratory developed tests, medical devices, and pharmaceuticals. Their healthcare specialization centers on navigating FDA regulatory requirements, international medical device directives (IVDR/MDR), and clinical laboratory standards (CLIA/CAP).

The firm's healthcare expertise includes companion diagnostics development, which requires coordination between pharmaceutical and diagnostic regulatory pathways. They have supported FDA pre-approval inspections and maintain specific knowledge of quality systems requirements for healthcare manufacturing environments.

The ideal client is an IVD, LDT, or medical device company preparing for FDA submissions (510(k), PMA, IDE) or seeking international market access through EU IVDR/MDR compliance. Organizations implementing or remediating quality management systems under FDA QMSR, ISO 13485, or CLIA/CAP standards will find relevant expertise. Companies developing companion diagnostics or laboratory-based tests requiring both regulatory strategy and clinical validation support align well with AltaQ's service portfolio.