Porzio Life Sciences provides Aggregate Spend Regulatory Compliance software solutions for Pharmaceutical, Medical Device & Biotech companies comply with Affordable Care Act and Sunshine Act.
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Aggregate Spend Solutions and Regulatory Compliance Products

Porzio Life Sciences’ regulatory compliance software solutions, products and services assist pharmaceutical, medical device and biotechnology companies in complying with marketing and sales regulations, including PDMA, anti-kickback statutes, False Claims Act, FDA, OIG, Physician Payments Sunshine Act, Affordable Care Act and state aggregate spend compliance regulations.

Porzio AggregateSpendID® is an automated web-based solution for spend and samples data capture, tracking and reporting.  The system collects spend associated with sales representatives, senior executives, medical meetings, clinical trials, grants, eGrants, speaking fees, honoraria, etc.

Products and Services

Porzio AggregateSpendID®— Web-based system to track spend and samples directed towards healthcare providers and organizations - read more 


Porzio Compliance Digest— Searchable databases of sales and marketing statutes, regulations and pending legislation - read more 


Distribution Licensing— Identify, acquire and amend required state distribution licenses for drug and device manufacturers and distributors - read more 


Significant Loss Threshold Assurance—Formula-based sample accountability - read more  
 

Porzio Compliance Modules— "At-a-glance" information, regulations and agency rules - read more 

News

Porzio Life Sciences, LLC (PorzioLS) announces the development of a Global Spend Transparency solution, Porzio GST™. The system provides an easy-to-use, configurable interface that will enable companies to capture and manage data elements necessary for meeting their reporting obligations in ex-US countries - Read more

Porzio Life Sciences Goes Global
International Life Sciences Transparency Database
 

Porzio Life Sciences, LLC, in collaboration with its French joint venture partner, Aubyn Life Sciences, announce the launch of the International Life Sciences Transparency Database (International Database).  The International Database contains invaluable guidance on non-US disclosure requirements pertaining to healthcare professional (HCP) and healthcare organization (HCO) payments - Read more

Porzio Life Sciences Opens a North Carolina Office to Serve Life Sciences Companies
Porzio has opened an office in Cary, North Carolina,  under the direction of Timothy  S. Ayers, a principal of the law firm in its Life Sciences Compliance, Commercialization and Regulatory Counseling Department - Read more

Porzio Life Sciences Celebrates Customer Service Week 2013
Porzio celebrates its 3rd Annual National Customer Service Week! - Read more
AdvaMed is the world’s largest medical technology association representing manufacturers of medical devices, diagnostics products, and medical information systems - Read more

Christine Bradshaw and Sarah Canberg Quoted in Article on the Sunshine Act’s Complexity
Christine N. Bradshaw, Associate of Porzio, Bromberg & Newman and Director of Regulatory and Compliance Services of Porzio Life Sciences, LLC and Sarah M. Canberg, Associate of Porzio, Bromberg & Newman and Manager of Regulatory and Compliance Services of Porzio Life Sciences, LLC are quoted in the Compliance Week article "Final Version Provides Little Relief for Complex Sunshine Act.” - Read more or go to Compliance Week

Scott Liebman and Christine Bradshaw Quoted in Article on the Finalization of the Sunshine Act 
Scott Liebman, Principal of Porzio, Bromberg & Newman and Vice President of Porzio Life Sciences and Christine Bradshaw, Associate of Porzio, Bromberg & Newman and Director of Regulatory and Compliance Services of Porzio Life Sciences are quoted in the article "The Sunshine Act is Finally Final" in the Pharma & Healthcare section of Forbes.com - Read more  or go to Forbes

Elizabeth Kim & Kiaema Reid, Co-Authors of Compliance Manual
Porzio Life Sciences’s Elizabeth H. Kim, Manager of Regulatory and Compliance Services and Kiaema Reid, Senior Regulatory Analyst, are contributors to the composition of the “Pharmaceutical and Medical Device Compliance Manual,” - Read more

More News


Careers

REGULATORY ASSISTANT and QUALITY CONTROL SUPERVISOR openings at our Morristown office​.

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Events

Kiaema Reid, Sandra Gonzalez, Jen Romanski, and Ed Crowe will be attending the FDLI Advertising and Promotion Conference in Washington, DC on September 29-30, 2014 - Read more
 
Michelle Axelrod, Jeff Campbell, Ed Crowe, and  Jennifer Romanski will be speaking at AdvaMed's Medical Technology Learning Institute's (MTLI) Compliance Essentials: Implementing an Effective Program in Washington, DC on September 23-24, 2014 - Read more
 
Tim Ayers will be speaking at The Asia-Pacific Pharmaceutical Compliance Congress and Best Practices Forum in Shanghai, China on September 16-18, 2014 - Read more
 
Ingrid Pelzer, Sandra Gonzalez, Maggie Lam, and John Oroho are attending The Annual Sharing Conference in Leesburg, Virginia on September 14-17, 2014 - Read more
 
John Oroho is speaking at the Seton Hall Life Sciences Compliance Program in San Francisco, California on September 8-10, 2014  - Read more

8th Annual Forum on Transparency & Aggregate Spend 
Jeffrey Campbell, Brian Sharkey, John Oroho, and Timothy Ayers are speaking at the 8th Annual Forum on Transparency & Aggregate Spend in Washington, DC on August 18-20, 2014 - Read more

Jeffrey Campbell is moderating and Sandra González is speaking at the Latin American Pharmaceutical and Medical Device Compliance Congress and Best Practices Forum in Mexico City, Mexico. Takes place on July 29-31, 2014 - Read more

CBI's Commercial Compliance Congress
Jennifer Romanski is speaking at CBI's Commercial Compliance Congress on how to Ensure Compliant Communication of Medical and Economic Value to Improve Market Access. Takes place on June 19-20, 2014 - Read more

Frank Fazio is speaking, John Oroho is moderating and Cindy Alvarado is attending the NSHMBA New Jersey 2nd Annual Regional Healthcare Summit in Montclair, NJ. Takes place on June 13, 2014 - Read more
 
Brian Sharkey is speaking at the CBI Publication and Clinical Trial Disclosure Forum in Dublin, Ireland.  Takes place on June 9-10, 2014 - Read more

More Events
 

Articles

Industrial Site Recovery Act: An Environmental Consideration For New Jersey Life Sciences Facilities
Life sciences companies must consider the applicability and requirements of various environmental laws and regulations that
may apply to operations and transactions.  Lisa M. Bromberg and Thomas Spiesman - Read more

FDA’s Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters
FDA’s Office of Prescription Drug Promotion (OPDP) issued a total of 24 enforcement letters to pharmaceutical manufacturers in 2013, 3 Warning Letters and 21 Untitled Letters - Read more

Getting the Deal Through: Life Sciences 2014 - United States Chapter Life Sciences in 24 Jurisdictions Worldwide
Article by John Patrick Oroho and Brian P. Sharkey - “In recent years, the United States has seen a significant increase in federal and state government-initiated enforcement actions against life sciences companies, many of which have resulted in multi-million, or even multi-billion, dollar settlements and penalties - Read more

Holland. The Original Cool.
Porzio, Bromberg & Newman P.C.
by D. Jeffrey Campbell and Brian P. Sharkey
The Dutch pharmaceutical industry has been ahead of the curve with respect to self-imposed transparency requirements - Read more or download full article.

Australia Takes Center Stage in the Global Debate Over Life Sciences Transparency: Legislation vs. Self Regulation 
Bloomberg BNA Pharmaceutical Law & Industry Report
by D. Jeffrey Campbell and Brian P. Sharkey - Read more or download full article
 
Porzio Life Sciences, LLC
by D. Jeffrey Campbell and Brian P. Sharkey - Read more or download full White Paper

EFPIA Leads the Self-Regulation Charge to Try to Avoid Government-Imposed Transparency 
The debate between government-imposed disclosure requirements and industry self-regulation supporters continues to heat up around the world and EFPIA is leading the movement toward self-regulation by its recent adoption of a new disclosure code - Read more