Compliance Services

Mitigate your risk.

In this business, what you don't know can hurt you.

Our regulatory experts get things right the first time time – and keep your business on track. So leverage our expansive regulatory, quality and compliance expertise to move with speed and certainty throughout the drug and device development lifecycle. There's no need to deploy your capital to build it yourself when our internal experts, best practices and systems stand ready to support your compliance needs.

Regulatory Strategy & Compliance

  • Regulatory Strategic Guidance
  • Regulatory Submissions & Lifecycle Support
  • Regulatory & Quality Consulting

Mitigate risk and enhance speed to market with the right regulatory and compliance specialists at your side.

  • Expedite drug development with expert regulatory strategy guidance
  • Access our broad expertise: IND/IDE/ PMA/NDA/BLA/MAA/Orphan/Breakthrough
  • Leverage our qualified experts in regulatory affairs and quality to ensure compliance across the lifecycle: Research to Phase IV

Quality Management

  • Part 11 Compliant Quality Management System
  • Fully Validated SOPs with Customization Features
  • CAPA Management

Leverage our cumulative quality experience that spans thousands of products and companies.

  • Maintain compliance throughout the lifecycle of your product
  • Gain peace of mind, knowing your quality program meets regulatory standards
  • Respond quickly and appropriately to identify root causes and implement system-wide improvements

$0

capital investment for QMS install & validation

Pharmacovigilance & Risk Management

  • Clinical Safety & Pharmacovigilance
  • Device Complaint & MDR Reporting
  • Signal Detection, Risk Management & Benefit Risk Evaluation
  • Periodic Safety Report Writing & Submission

Safeguard your product's reputation with our integrated approach to drug safety.

  • Get up and running quickly with our fast and flexible client implementation
  • Take advantage of our U.S. and EU pharmacovigilance regulatory expertise
  • Integrate with in-house and external regulatory stakeholders
  • Use our validated safety database for accurate and timely regulatory reporting

>99%

on-time adverse event case processing

Medical Information & Communications

  • Medical Information Call Center
  • Clinical Trials Support Services
  • Medical Writing

Build credibility and strengthen your relationships with healthcare providers, patients and payers.

  • Don't just answer questions, solve problems using our extensive team of clinicians
  • Simplify your clinical trial enrollment process with our PharmD-staffed hub
  • Let our clinically-trained medical writers help you build awareness of your product's benefits

90%

of team comprised of PharmDs

Project Management & Consulting

  • Portfolio & Project Management
  • Coordinate & Track Project Deliverables to Timeline
  • Project Management System Installation & Operation

Comprehensive project management to help you avoid missed deadlines.

  • Augment your organization with project management professionals
  • Keep your project teams on time and within budget
  • Implement our hosted Project & Portfolio Management Systems