About AltaQ
Our Team
Our Expertise
Regulatory Affairs
Quality and Compliance
Software Compliance
Clinical Affairs
Validations
LDT/CLIA
QMSR/QSR
EU IVDR/MDR
Our Focus
In vitro Diagnostics
Laboratory Developed Tests
Medical Devices
Digital Health
Blogs
Let's Connect
Regulatory Submissions
We do not just tell you what to do, but work with you to achieve results.
Successfully completed regulatory submissions for IVD, LDT, and Medical Device companies.
We can help as part of your team to design and execute studies to achieve regulatory submission target milestones.
Let's talk
PMA
Pre-Market Approvals (PMAs) for IVD and medical devices
510(k)
Traditional, Abbreviated, and Special 510(k)
NYS - CLEP
New York State - Clinical Laboratory Evaluation Program
EU MDR
Medical Device Regulations (MDR) for medical devices - CE Mark
International
PMDA (Japan), NMPA (China), TGA (Australia), etc.
De Novo 510(k)
De Novo 510(k) for IVDs and medical devices
IDE
Investigational Device Exemptions (IDEs)
Pre-Submissions
FDA pre-submissions (Q-subs) for IVD and medical devices
EU-IVDR
In-vitro Diagnostics Regulations (IVDR) for CE Mark
Efficient
Effective
Reliable
Efficient
Effective
Reliable
Efficient
Trust
Responsibility
Results
Trust
Responsibility
Results
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 are able to build and trust with our clients and retain of clients for multiple years.
Recent articles
See all articles
The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?
The FDA's LDT Rule Explained
