With more than 80 FDA submissions, DOCRO is an experienced CRO that provides ACSL customers with a clear path and understanding of how to commercialize IVD products.
The co-marketing agreement with DOCRO provides ACSL customers with access to a full suite of validation and regulatory clinical trial services and resources.
For the past 10 years, DOCRO has a proven formula for success that has led to an unparalleled track record with the FDA, making DOCRO the clear choice for FDA pre-market approvals.
We are very excited to work with the highly experienced and enthusiastic team at DOCRO," said Cynthia French, Ph.
DOCRO is headquartered in Seymour, Connecticut, and has been servicing the IVD industry for more than 10 years.
is setting up a meeting with the FDA and AMDL to discuss the FDA's specific concerns which are necessary to grant marketing approval.
has a diverse and extensive experience with a wide variety of biomarkers and other proteomic or genomic diagnostic tests, of which, many are now standard of care biomarkers in the field of oncology, cardiology and infectious disease.
DOCRO is an internationally recognized Connecticut-based company (www.
Lexon has retained DOCRO to configure the Ebaf Assay(TM) for the ELISA platform, a generally accepted immunological testing format used worldwide.
Dreher, President of AMDL, reported that DOCRO
believes the DR-70(R) test is substantially equivalent, and is confident that the deficiencies noted by the FDA can be overcome.
DOCRO assists members of these industries in the development, clinical validation, approval and sale of new products.
By improving the cost-effectiveness and decreasing the duration of these studies, DOCRO helps companies submit applications to the FDA faster.