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NEWS

FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format... Read more US FDA FY 2019 MDUFA User Fees... Read more E&L Chemical Characterization & Hexane Extracts: GC vs. LCUVMS Analysis... Read more APS Adds Capacity, Capabilities, and Competencies to its Research Campus... Read more Medical Device Innovation: Dealing with Challenges... Read more APS Regulatory Update: FDA Delays UDI Enforcement for Class I and Unclassified Devices... Read more FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)... Read more FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework... Read more Strengthening EU-US cooperation in medicine inspections... Read more FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018... Read more
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Regulatory Consulting Services

Helping you get your product to market.

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Interventional & Surgical Research

Bringing your medical device development to the next level. APS has the cutting edge tools and techniques to advance your preclinical program.

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Biocompatibility Testing

APS will recommend only the testing necessary for your product. Our approach leads to a reduction in product usage, timelines and cost.

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Pain Research

Screening large numbers of compounds or characterizing a single compound? APS offers 20 validated rodent models for assessing novel analgesic therapies.

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Toxicology and Pharmacology Studies

Specializing in early screening, late stage development and GLP safety assessments of drugs and biotechnology platforms.

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Analytical Testing & Development

Providing a full range of analytical services to facilitate integration and overlapping of various study components

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Pathology Services

The gold standard for the evaluation of medical product safety. APS is committed to the success of your preclinical program.

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Bioskills Labs

Combining our access to tissues with our equipment and expertise, allows us to provide physician bioskills labs and device evaluations at the highest levels.

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Physician Training & Simulation Labs

Optimizing the learning experience within a clinically simulated environment. APS’ operating, cath lab and CT suites are second to none.

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APS Facility Tour

Tour our world class preclinical center of excellence today and see what sets us apart from the rest.

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