Regulatory, Quality and Clinical

Experts for IVD/LDT, Medical Devices, Digital Health, and Pharmaceutical industries

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Services

SERVICES

Our significant and integrated experience enables us to implement industry practices to achieve results.

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, and CLIA/CAP

LDT - CLIA/CAP

Extensive experience in CLIA/CAP-based LDTs to meet the FDA and IVDR requirements

EU IVDR and MDR

The 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, Process, and Facility Validations.

Software QA

We have extensive experience in developing software documentation covering FDA submissions.

Clinical Affairs

We develop and execute clinical validation protocols and plans for regulatory submissions.

An integrated regulatory, quality, and clinical system with effective program management saves time and cost.

10+

Qualified Experts

30+

Years of serving diagnostic and medical device companies

100%

Retention rate with our clients

We provide services to various life sciences 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 the USA, 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.