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

Looking Back at What's to Come: Highlighting 2014 Key Events to Develop 2015 Best Practices. 
We are pleased to announce our first-ever Porzio Life Sciences' 2014 Year-End Report. This year's Report is a compilation of updates and changes related to life sciences companies' compliance with marketing and sales regulations - Read more

New and Improved Porzio Compliance Digest
Porzio Life Sciences is pleased to announce the redesign of the Porzio Compliance Digest (PCD) - Read more
Announcing the hiring of Peter A. Zaudtke, Jr., Holly K. Kramen, J.D., Michael R. Bartholomew, Sharon O. Small, J.D. and Betsy C. McSheffrey, J.D. to better serve the firm's growing client base - Read more

Porzio Life Sciences Celebrates National Customer Service Week 2014 
October 6-10, 2014
Porzio Life Sciences celebrates its 4th Annual National Customer Service Week by hosting five days of interactive internal events - Read more
The new office serving clients nationally and in Europe, will be led by Kevin Bell, Scott Chambers and Richard Oparil, intellectual property lawyers - Read more or Download (PDF)

Transparency is Sweeping the Globe 
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


Careers

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

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Events

Michelle Axelrod is speaking at The New England Healthcare Compliance Roundtable in Newton, MA on March 27, 2015 leading a Roundtable on Difficult Healthcare Compliance Issues for Medical Device Companies - Read more

3rd Annual CBI Compliance Monitoring Forum
Holly Kramen is speaking at the 3rd Annual CBI Compliance Monitoring Forum in Philadelphia, PA on March 18-19, 2015 - Read more

2015 Synergistix Users Conference
John Oroho is speaking at the 2015 Synergistix Users Conference in Deerfield Beach, FL on March 11-13, 2015 - Read more

HDMA 2015 Distribution Management Conference and Expo
Michael Bartholomew and Frank Fazio are attending the HDMA 2015 Distribution Management Conference and Expo in Orlando, FL on March 8-11, 2015 - Read more

CBI's 12th Annual Pharmaceutical Compliance Congress 2015
Jeffrey Campbell, John Oroho, Brian Sharkey and Timothy Ayers are speaking at CBI's 12th Annual Pharmaceutical Compliance Congress in Washington D.C. on March 3-4, 2015 - Read more
Michelle Axelrod is speaking at the DRI Women in the Law Seminar in Fort Lauderdale, FL on February 26-27, 2015 - Read more

John Oroho is speaking at the CBI Sample Compliance and Reporting Summit in Philadelphia, PA on February 25-26, 2015 - Read more

Timothy Ayers  is speaking at and Peter Zaudtke is attending the 8th Annual CBI Oncology Commercialization & Market Access in San Francisco, CA on February 24-25, 2015 - Read more
 
Sandra Gonzalez and Jen Romanski are attending the DIA Marketing Pharmaceuticals 2015: Drug/Device Marketing in an Evolving Environment in Washington, DC on February 18-19, 2015 - Read more
 
Holly Kramen is speaking at and Ed Crowe is attending the 11th Compliance Congress for Medical Device and Diagnostics in Chicago, IL on February 11-12, 2015 - Read more
 
Michael Bartholomew is speaking at the 4th CBI Hub Models and Program Design in Philadelphia, PA on February 5-6, 2015 - Read more

Scientific Publications and Transfer of Value Reporting Webinar 
Brian Sharkey is co-presenting a Q1 Productions Scientific Publications and Transfer of Value Reporting webinar at 1 pm on Tuesday, January 27, 2015 - Read more

More Events
 

Articles

HIPAA and MOBILE HEALTH APPS: What developers need to know about app user privacy 
Cooler weather and a new crop of Apples have become the tell-tale signs of autumn and the hot season for new technology - Read more 

Consent: Find Out What it Means to You 
by Brian Sharkey, J.D.
The intersection of the data privacy protections afforded to European Union citizens and the implementation of EFPIA's Disclosure Code - Read more

New statutes and regulations lacking purpose and reason is causing over regulation of pharmaceutical industries - by Frank Fazio - Read more
 
Massachusetts based life sciences companies are at a disadvantage due to difficulties obtaining non-resident distribution licenses - by Frank Fazio -   Read more

by D. Jeffrey Campbell and Brian P. Sharkey - Read more or Download full White Paper

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