Category: Safety Assessment

Get to Know Aclairo

Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance. Aclairo’s unique experience and capabilities help our clients’ development programs succeed. Our senior consultants are experienced ex-FDA […]

Clinical Pharmacology & ModelingDiscoverySafety AssessmentToxicology

EPL’s SEND Capabilities

The Standard for Exchange of Nonclinical Data (SEND) provides preclinical study data standards that will allow for a more consistent and streamlined review process by the US FDA.  In general, SEND formats apply to studies started after Dec. 17, 2016 for NDAs, BLAs, and ANDAs, and studies that start after Dec. 17, 2017 for INDs. […]

PathologySafety AssessmentToxicology

EPL to Participate in Webinar: Using Electron Microscopy in Nonclinical Studies

Dr. Tom Steinbach from EPL will be the featured speaker for the Webinar titled, “Using Electron Microscopy in Nonclinical Studies,” which is jointly sponsored by the Society of Toxicologic Pathology-India (STP-I), International Federation of Societies of Toxicologic Pathologists (IFSTP), and International Academy of Toxicologic Pathology (IATP). This webinar will be held on Thursday, May 25, […]

PathologySafety AssessmentToxicology

Experimental Pathology Laboratories and WestChina-Frontier PharmaTech Form Strategic Alliance for Preclinical Services

Experimental Pathology Laboratories, Inc. (EPL), and West China-Frontier PharmaTech Co., Ltd. (WCFP) announce a Strategic Alliance to enhance Preclinical Services. This alliance is targeted to bolster the rapid growth of WCFP by specifically providing EPL’s Pathology Peer Review Services for WCFP projects that are being submitted to international regulatory agencies. WCFP is experiencing rapid growth […]

PathologySafety AssessmentToxicology

Experimental Pathology Laboratories, Aclairo Pharmaceutical Development Group, and Expedient Solutions International Form Strategic Alliance to Enhance Pathology and Regulatory Consulting Services to the Greater China Region

Experimental Pathology Laboratories, Inc. (EPL), Aclairo Pharmaceutical Development Group, Inc. (Alcairo), and Dr. Ada H.C. Kung with Expedient Solutions International (ESI) announce a new strategic alliance to enhance Preclinical Pathology and Regulatory Consulting Services to the Greater China pharmaceutical and biotechnology industry.  This alliance is targeted to expand and enhance EPL, Aclairo, and ESI’s capabilities […]

PathologySafety AssessmentToxicology

EPL to Exhibit at the 56th Annual Society of Toxicology (SOT) Meeting

EPL will once again be exhibiting at ToxExpo™ in Baltimore from March 13-15, 2017.  If you are attending the 56th Annual Society of Toxicology Meeting, please visit our teams from EPL and Aclairo; we will be exhibiting in Booth #2332. Please stop by and visit EPL if you are in Baltimore!  For more information about the SOT, […]

DiscoveryPathologySafety AssessmentToxicology

A Closer Look at Ocular Toxicity Studies

The eye and the ocular adnexa are common target organs in toxicology studies, but the appropriate evaluation of ocular tissues is a specialized endeavor.   Compared to routine toxicity studies, ocular toxicity studies require methodological modifications at almost every stage from study design to the final pathology report. EPL has extensive experience in the processing and […]

HistologyPathologySafety AssessmentToxicology

The Benefits of Entrusting Your Histopathology Services to EPL

Companies who outsource the histopathology component of their valuable studies need to know that the work will be performed to the highest quality standards, on time, and at competitive prices.  Although claims of quality are easily made, true quality can be a difficult metric to gauge.  So let’s look at the evidence. Unlike its few […]

Biological TestingDiscoveryHistologyPathologySafety AssessmentToxicology

EPL Announces New President

EPL is pleased to announce the promotion of Dr. Kathleen Funk to President of EPL on June 1, 2016.  Dr. Funk has served as the Chief Operating Officer since 2014.  Dr. Funk is a graduate of the Virginia-Maryland Regional College of Veterinary Medicine and also holds a PhD in Comparative Pathology from the University of […]

HistologyPathologySafety AssessmentToxicology

EPL and Histion Form Strategic Alliance to Enhance Medical Device and Biomaterial Testing

EPL announces a newly formed strategic alliance with Histion, an Everett, Washington based preclinical laboratory specializing in GLP-compliant routine and specialty histology and evaluation services.  This alliance is specifically targeted to expand and enhance EPL’s and Histion’s capabilities to an ever expanding area of medical device and novel biomaterial testing.  Although Histion specializes in processing […]

Biological TestingDiscoveryHistologyPathologySafety Assessment