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Research supplier
PDS Life Sciences
PDS Life Sciences is listed as a small business research supplier in the Scientist.com network, with 3 sites in 3 countries.
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Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small business
Biomarkers
- Histopathology Evaluate slide preparation of cells or tissues for abnormal features.
Cell Culture and Characterization
- Histology Examine by microscopy the anatomy of cells and tissues of clinical patients and animal models.
Chemical and Compound Testing
- Clinical Pathology Diagnose disease based on the laboratory analysis of bodily fluids, such as blood, urine and tissues.
Clinical Consulting
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
Data Science/Bioinformatics
- Discovery Data Management A process that includes acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data for its users.
General in vivo Toxicology
- General Toxicology Use in vivo models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.
- IV Toxicology Test the toxicological effect of IV delivery of drug candidate.
Scientific Data Services
- System Development Plan, create and deploy an information system.
Where it operates
Sites by country, with the cities in each.
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Japan 1 site
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Switzerland 1 site
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United States 1 site
About this supplier
In the supplier's own words, as listed in the Scientist.com network.
FDA SEND compliant export of preclinical study data Introduction In 2012 FDA was granted the mandate to require that clinical and nonclinical pharmaceutical regulatory submissions conform to an electronic standard. This mandate extends to specification of the standard and timeline for implementation. Not only will FDA require SEND (Standard for the Exchange of Nonclinical Data) for nonclinical portions of pharmaceutical regulatory submissions, they will also use SEND datasets to analyze these submissions. Conformance to the SEND electronic standard and additional business rules will...
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FDA SEND compliant export of preclinical study data
Introduction
In 2012 FDA was granted the mandate to require that clinical and nonclinical pharmaceutical regulatory submissions conform to an electronic standard. This mandate extends to specification of the standard and timeline for implementation. Not only will FDA require SEND (Standard for the Exchange of Nonclinical Data) for nonclinical portions of pharmaceutical regulatory submissions, they will also use SEND datasets to analyze these submissions. Conformance to the SEND electronic standard and additional business rules will determine whether FDA will deem SEND submissions suitable for review.
Facts
Although the FDA requirement for SEND submissions goes into effect starting in December of 2016, there are compelling reasons to become SEND compliant as soon as possible. The FDA is currently reviewing SEND submissions at this time and it is their preferred format already today. Data submitted in the SEND datasets is being reviewed significantly faster versus data from tables included in toxicology reports. To ensure SEND readiness, FDA recommends that each sponsor submit three SEND trial submissions in advance of an actual SEND submission.
Solution
PDS provides the all-encompassing services to get your preclinical data SEND-ready. PDS aggregates and translates data to produce SEND export files, including the Study Data Reviewer's Guide as recommended by the FDA.
From assessment, to implementation, to comprehensive submission guidance, including preparation of many successful SEND submissions, PDS is your all-in-one FDA-compliant partner for SEND.
About
PDS is a privately owned, Swiss-born provider of software and solutions for life sciences research & development and regulatory submissions. For more than 30 years, we’ve developed software and services by scientists, for scientists — a hallmark that is unrivaled in our field. For that reason, eight of the world’s top 10 pharma companies rely on PDS software and services, as do industry-leading CROs, chemical companies, universities and regulatory agencies. With offices on three continents and clients spanning North and South America, Europe and Japan, we are a truly global company.
- Website
- www.pdslifesciences.com
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