Life Sciences Industry Life Sciences

Specialized deployment of Quality, Validation, Regulatory, and Biometrics consulting and talent solutions to keep your pharmaceutical, biotechnology, or medical device company focused on what matters: products that save lives.

How We Help You

The ever-changing regulatory landscape, the balance between efficacy and safety, as well as increased pricing pressures and speed to market have all contributed to the level of uncertainty - but also opportunities - for life sciences organizations. There is heightened awareness for delivery, innovation, and continuous improvement that can only come from trusted, scalable solutions that include processes and talented staff who can lead the charge.

Key challenges include:

  • Warning letter remediation
  • Pre-Approval inspection preparation
  • Complaint handling remediation
  • Regulatory Filings
  • Audits
  • Data Analysis and Standardization
  • Submission support
  • Rescue work

We work with your company to address current challenges, as well as long term goals, and provide you with the tools and talent you need to remain competitive in the life sciences marketplace.

Examples of Customer Success

  1. FDA Corporate Warning Letter Remediation at a Multi-National Medical Technology Company
  2. FDA Pre-Approval Inspection Preparation for a Biopharmaceutical Company
  3. Complaint Handling Remediation for a Global Leader in Cardiac Care