experts for IVD/LDT, Medical Devices, Digital Heath, and Pharmaceutical industries
Regulatory Affairs
We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.
Quality Assurance
Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, CAP/CLIA.
LDT - CLIA/CAP
Extensive experience in iCLIA/CAP based LDTs to meet the FDA and IVDR requirements.
EU IVDR and MDR
AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.
FDA QMSR ISO 13485
AltaQ has expertise in integrating FDA QMSR and ISO 13485.
Validations
We help in developing and executing Analytical, Software, and Process, and Facility Validations
Software QA
We have extensive experience in developing software documentation covering for FDA submissions.
Clinical Affairs
We develop and executes clinical validation protocols and plans for regulatory submissions.
An integrated regulatory, quality, and clinical within an effective program management saves time and cost.
100%
retention rate with our clients
30+
years of serving diagnostics and medical device companies
Our significant and integrated experience enables us to implement industry practices to achieve results.
AltaQ supported companies worldwide covering the USA, EU, Japan, and Australia to meet the regulatory, quality, and clinical needs!
We provide services to various life science industries
This includes: In vitro diagnostics (IVD), Laboratory Developed Test (LDT), Medical Devices, and Pharmaceuticals.
IVD/LDT
The AltaQ team has been serving the IVD/LDT industry for more than 30 years. Team members have successfully completed regulatory, quality, software compliance, and validation related projects including companion diagnostics (CDx).
Medical Devices
We serve the global medical device industry and provide regulatory services covering FDA and international submissions, QA, Software, and Validations. We have completed projects in theUSA, Europe, Japan, South Asia and China.
Pharma
AltaQ provides regulatory compliance services covering QA and validation services for the pharmaceutical industry. Team members have supported FDA pre-approval inspection (PAI) including process, equipment, facility, and computer systems
Schedule a call with us!
We provide free initiation assessment and consultation.
