Product Sampling

Porzio’s industry and operational knowledge is key to providing clients with practical business solutions that comply with FDA and state sampling and distribution requirements.  Porzio attorneys not only possess comprehensive legal and regulatory knowledge of field-based and direct-to-practitioner sampling programs, but also understand the operational and business challenges companies face.

In our a holistic approach to sample compliance programs, we:

  • Implement sample compliance programs
  • Assess sample compliance programs
  • Conduct gap analysis of sample compliance programs
  • Identify and assist with implementation of corrective measures
  • Develop or assess sampling policies and procedures
  • Develop or assess inventory and reconciliation processes
  • Develop audit programs

In addition, we counsel clients on FDA and state reporting obligations and establishing significant loss and related loss thresholds. Porzio attorneys have experience serving on internal Sample Compliance Committees, providing advice on disciplinary measures for compliance deviations, and counseling on federal and state reporting obligations.

In addition to the legal and regulatory advice offered by Porzio, our subsidiary, Porzio Life Sciences, LLC (PorzioLS), provides an array of sample-related products and services.  The following sampling and distribution databases are available within the Porzio Compliance Digest (PCD):

  • Distribution: Trade and Sample - Legend Drug Database
  • Distribution: Trade and Sample - Controlled Substance Database
  • Distribution: Prescription Device Database
  • Mid-level Regulations Legend Drug Database
  • Mid-level Regulations Controlled Substance Database

Together, Porzio and PorzioLS offer complete compliance solutions to address the product sampling needs of life sciences companies.