Regulatory Solutions for the Life Sciences Industries to Achieve Successful Results
AltaQ provides global regulatory, quality, compliance, and validation consulting services. We believe in developing efficient and cost-effective regulatory solutions by understanding clients' needs and applying industry best practices to achieve success in the in-vitro diagnostics, medical device, and pharmaceutical industries.
The AltaQ team has been serving the IVD industry for more than 25 years. We have successfully completed regulatory, quality, software compliance, and validation related projects included companion diagnostics (CDx) and NGS.
We serve the global medical industry and provide regulatory services covering FDA and international submissions, Quality Assurance, Software Compliance, and Validations. This also includes US market entry support for international clients. In addition to the USA, we have successfully completed projects in Europe, Japan, South Asia and China.
AltaQ provides comprehensive regulatory compliance services covering quality assurance and validation services for the pharmaceutical industry. Our team has successfully supported FDA pre-approval inspection (PAI) as a part and full qualification covering process, equipment, facility, and computer systems.
AltaQ believes in developing the efficient and cost-effective regulatory solutions by understanding clients' needs and focusing on process efficiency by minimizing paperwork. Our staff has helped companies in the USA, Europe, Japan and China to successfully meet regulatory requirements.
AltaQ helps medical device and in-vitro diagnostics companies to implement effective regulatory strategies to complete regulatory projects covering IDE, 510(k), de novo 510(k) and PMA. Our team members have successfully led projects from FDA pre-submissions through achieving clearances and approvals. We incorporate project management techniques to develop and monitor regulatory plans to achieve regulatory milestones.
QUALITY ASSURANCE & COMPLIANCE
We provide effective and efficient solutions to meet quality system and regulatory compliance requirements with significant improvements in product quality and product workflows. AltaQ's team has extensive experience working with the FDA requirements covering 21 CFR parts 820, 211, 210, 1271, and 606. We have developed and implemented integrated quality systems supporting FDA and international regulations and standards.
Our experts at AltaQ help companies to effectively meet software compliance and validation requirements. This includes establishing compliance processes for full SDLC (Software Development Life Cycle) and software validation including compliance with 21 CFR and Part 11.
AltaQ offers a full range of validation services to medical device, pharmaceutical, and biotechnology companies from planning through execution and final reporting. This includes validation activities covering product, process, system, equipment, facility and more.