In Vitro Diagnostics

Laboratory Developed Tests (LDTs)

Cost-effective and efficient compliance with the LDT rule

LDT - CLIA/CAP

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

Quality Assurance

Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, and CLIA/CAP

Regulatory Affairs

We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.

QMSR ISO 13485

AltaQ has expertise in integrating FDA QMSR and ISO 13485.

EU IVDR

The AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.

Validations

We help in developing and executing Analytical, Software, Process, and Facility Validations.

Software QA

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

Clinical Affairs

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

Our experience is our key asset and building trust is our goal!

30 yrs

Our team members have been serving the life science industry for more than 30 years.

100%

return and retention rate

We are proud that we have been able to build trust with our clients and retain clients for multiple years.

Recent articles

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The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?

The FDA's LDT Rule Explained

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 CAP/CLIA.

LDT - CLIA/CAP

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

EU IVDR

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 for FDA submissions.

Clinical Affairs

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