Global Compliance and Consulting Services

At Porzio Life Sciences, our products are "built from the law", but we don't stop there. For pre-commercial companies that may not yet need full compliance tracking and reporting solutions, or commercialized companies with needs that don't fit with a specific solution, our team of regulatory compliance experts are ready to give you the help you need.

We work with companies to provide custom solutions across the full life sciences compliance life cycle. Our team of former in-house compliance and legal professionals understand this complex landscape and the impact it has on your business. Our tailored approach enables you to accomplish your compliance goals in a way that works for your team, your process, and your budget.

Here is how we can help

Customized Compliance Modules

Our custom designed compliance modules are tailored to your specifications to an easy-to-use resource on state, federal, and global requirements.

Topics include:

  • 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

U.S. and Global Transparency Data Management

Data review and remediation is time intensive and overwhelming. Our team of regulatory professionals can help with:

  • 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

U.S. and Global Transparency Reporting Management

Our team of subject matter experts can help your company with transparency report generation, review, approval, submissions, and disclosures across U.S. and global jurisdictions.

We help companies:

  • Identify reportable spend types
  • Assess and identify jurisdictions where you have reporting obligations
  • Collect and standardize data to identify gaps and inconsistencies
  • Investigate missing or invalid data elements
  • Prepare and review draft reports for quality control
  • Report submission requirements and processes

Compliance Monitoring, Data Analytics & Risk Analysis

Analyzing data to mitigate risk is an essential parts of any compliance program. Our team can help you understand what data to analyze to help you make informed decisions on high-risk engagements that pose risks of FCPA or anti-bribery violations.

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75

Compliance Professionals

25

Life Sciences Lawyers

1

Comprehensive Risk Management Platform

Contact Us

Interested in learning more about how the team of experts at Porzio Life Sciences can help pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment? Please reach out with any questions.

We look forward to hearing from you.