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Regulatory Affairs

Regulatory Affairs

We address the needs of our clients for their most pressing regulatory issues and demands.

Past Performance for Successful Outcomes

We have supported small, mid-sized, and large global pharmaceutical and clinical research companies with professionals who understand the intricacies of regulatory requirements of NDA submissions and FDA guidelines related to ICD coding.  The time and frustration saved from an effective QA and compliance program staffed with talented medical writers, coders and auditors is invaluable to ensure a project is moved through the phases of development and we are there to provide resources throughout the process.

Resources and Personnel

We offer customized human capital solutions, specialized consulting and recruitment services covering a wide range of biotechnology programming, operations, and R&D skill sets.  The demands of our customers vary, so our focus is to understand the critical aspects of each customer and project, allowing us to be ‘ahead of the curve’ when you need it most.

  • Medical Writing
  • Protocol Development
  • Medical Coding
  • Regulatory Affairs Management
  • Quality Assurance
  • Regulatory Auditing
  • Compliance Auditing
  • Technical Writing

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