Compliance Services

If your life sciences company is trying to find answers for issues that are not fit for an out-of-the-box solution, our team of regulatory compliance experts and business services professionals are committed to getting you the support, expertise and results you need. 

Consulting services are provided on wide-ranging regulatory compliance issues, from reporting and data services, global transparency and risk mitigation to product development. PorzioLS partners with you to create a tailored plan that accomplishes your companies' goals in a way that works for your team, process and budget.

Customized Porzio Compliance Modules

If you don’t see a product on our website that fits your compliance needs, then we can design one just for your company. 

Our Customized Porzio Compliance Modules (Customized PCMs) provide information in an at-a-glance format that is tailored to our customers’ specifications. In preparing a Customized PCM, we organize state, federal or global requirements into a practical and easy-to-use resource. 

Customized PCMs are designed with your particular compliance needs in mind and can be provided as a one-time project, or on a quarterly or monthly basis.   

Popular Customized PCM Topics:

  • Mid-level Practitioner Prescriptive and Sampling Authority Requirements
  • Theft/Loss Reporting Requirements
  • Controlled Substance Reporting Requirements
  • Facility Licensing Requirements
  • Tracking Specific Legislation Topics
  • Pedigree: State and Federal
  • Product Specific Sampleability

 

Data Management

What comes next, after selecting an aggregate spend system and collecting your data?  

Our team of subject matter experts can help your company with managing its data collection, review and remediation processes. 

The data management process is time intensive and can be overwhelming. Let our team of regulatory professionals use their extensive knowledge and experience to fulfill your needs by facilitating:

  • Spend and sample data corrections
  • Business solutions for data capture and remediation
  • Recipient, nature and purpose type value mapping to the corresponding jurisdictional values
  • Preparation of assumptions documents
  • Data auditing and monitoring
  • Internal personnel training

If your company utilizes our Porzio AggregateSpendID or Porzio GST systems, we can also assist with:

  • Manual HCP matching
  • Manual data entry and file loads

Reporting Management

Our team of subject matter experts can help your company with managing its processes for generating, reviewing, approving and submitting aggregate spend and transparency disclosure reports.  

The report management process requires a deep understanding of each jurisdictions' aggregate spend or transparency requirements and the review of countless lines of data. Let our team of regulatory professionals use their extensive knowledge and experience to fulfill your needs by facilitating: 

  • Identification of reportable spend types
  • Assessments to identify jurisdictions in which your company has reporting obligations
  • Collection and standardization of data to identify gaps and inconsistencies
  • Investigation into missing or invalid data elements
  • Preparation and quality control review of draft reports
  • Report submission requirements and processes

If your company utilizes our Porzio AggregateSpendID or Porzio GST systems, we can also assist with: 

  • The generation of Compliance and Companion Reports
  • Quality Control review of reports to identify areas of concern and processes for remediation

Compliance Monitoring, Data Analytics & Risk Analysis

In a world full of data, analysis and monitoring are essential parts of any compliance program. Deciding what data to analyze, and what constitutes a "red flag" is one of the biggest challenges facing compliance professionals today.

PorzioLS understands the regulatory environment and offers analysis and insights to help mitigate compliance and legal risks for life sciences companies. Through the use of publicly available data, our own acquired data, and your data, PorzioLS can evaluate risks and provide actionable analysis so companies can make informed decisions relevant to essential business operations:

  • HCP Congress Sponsorships
  • Speaker Programs
  • HCP General Payments
  • Travel and Expenses
  • Payments potentially covered under FCPA and other anti-bribery laws
  • And many others

The PorzioLS Advantage

  • Knowledge - Supported by the parent company, Porzio, Bromberg & Newman, a leader in legal, regulatory, and compliance counseling to life sciences companies.
  • Experience - Operationalized compliance for over 400 life sciences companies.
  • Information - Utilization of Porzio Compliance Digest, an interactive database on state, federal, and global laws, regulations, and pending legislation governing the life sciences industry.
  • Skills - Regulatory and compliance professionals support the full life cycle of compliance monitoring (Collect, Analyze, Identify, Recommend, Implement).

Under the PDMA, life sciences companies are required to report a “significant loss” of prescription drug samples to the FDA.

The Prescription Drug Marketing Act sets timelines for loss reporting and investigation but does not define “significant” or provide factors for consideration in determining significant losses.

Life sciences manufacturers and distributors are tasked with delineating consequential losses based on their business models.

According to the FDA's Guidance, "each manufacturer or authorized distributor is expected to establish its own threshold for determining when inventory that cannot be accounted for is significant. This threshold should be derived from each firm’s past experience in prescription drug sample distribution and inventory, and should be based on the level of accuracy of the firm’s internal audit and security procedures."

Many organizations have assigned arbitrary percentages or dollar amounts as loss thresholds. Some companies set thresholds of 10% of the quantity distributed or 5% of the product cost.

Unfortunately, quantitative calculations do not account for the nature of products.  To avoid over and under-reporting, companies must consider qualitative factors, such as the potential for product abuse or diversion.

PorzioLS created Significant Loss Threshold Assurance, a customized, formula-based approach to sample accountability with 16 key variables for successful significant loss threshold determination. 

Our proprietary formula determines thresholds that account for a company’s distribution model, historical sample loss records, and full product portfolio.  The formula incorporates critical factors, including:

  • Product Safety
  • Loss History
  • Shipment and Distribution Volume
  • Risk of Diversion

As your company’s distribution model or product portfolio evolves, we can promptly reassess your sample data to ensure continued compliance.

37 Ex-US Jurisdictions Served

3 Offices

370 Companies Served

Questions? Request more information or call 973-538-1690

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