Pyrodex Testing's Capability Statement
DUNS: 83510589
CAGE CODE: 84SF7
NAICS CODES (commonly supported): 541714
541715, 325412, 326299, 334513, 332911, 611430, 621410
Our Core Beliefs:
More comprehensive safety testing to detect contaminants will result in safer drugs for clinical trials, more effective treatments, more lives saved, and better return on investment (ROI).
Many clinical trials fail not because of drug inefficacy or device engineering flaws, but because of contaminants that are undetected by the current standard safety testing methods.
Our Mission: To help medical device and drug makers increase success rates in clinical trials and accelerate commercialization.
Our Vision: Safer treatment for all.
DJIKOLNGAR MAOUYO, PhD
Managing Director/President
(443) 459-1374 (443) 722-5498 (877) 381-2455
701 East Pratt Street, Room 5088, Baltimore, MD 21202
CERTIFICATIONS & LICENSES
WHO WE ARE
Established in 2017, we bring more than 15 years of experience in the biotech industry focusing on biosafety testing for all levels of public and commercial health care organizations.
Our biotech company offers rapid testing and comprehensive detection of pyrogenic contaminants in injectable or implantable medical drugs and devices, using technologies that do not rely on animal testing or animal products.
We provide accurate, reliable test results based on 36 or 108 replicates for each sample within 5 business days, using a definitive product pyrogenicity profile.
We help drug manufacturers increase success rates in clinical trials and thus accelerate commercialization.
We are committed to helping manufacturers ensure medical drugs and devices released for clinical applications are truly safe.
WHAT WE DO
We DETECT:
A full range of pyrogenic contaminants
Pyrogenic lipopolysaccharide contaminants
Non-LPS pyrogenic contaminants
Conspicuous or insidious toxicity
Chemical impurities
We ELIMINATE:
Unnecessary patient risks or compromise of clinical trials.
The risk of error inherent in the use of commercially available MAT kits.
Clinically irrelevant supplemental tests
We PROVIDE:
Safety information on injectable drugs
Quality control of blood products
Safety testing for implantable medical devices
Results in less than 5 business days
