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Regulatory Strategy & Consulting

EVERSANA’s Regulatory Consulting helps businesses succeed by partnering with clients to solve a wide range of regulatory challenges. Our strategic advisors, who are experts in pharmaceuticals, medical devices, and emerging biotechnology, work closely with clients to develop and implement customized regulatory solutions. Through our integrated services, we support companies in achieving their business objectives.

Whether it’s crafting a comprehensive product portfolio strategy, augmenting your regulatory team with associate to executive placements, or offering advisory services for specific problems, we are your trusted partner in navigating the complex regulatory landscape.

Areas of Focus

Our team of regulatory experts help businesses of all sizes meet complex regulatory requirements and achieve their business goals. We have a proven track record of success in a range of diseases and domains where we offer support in the following therapeutic areas:

  • Cardiovascular, Hematology, Endocrinology and Nephrology
  • Cell and Gene Therapy
  • Immunology and Inflammation
  • Infectious Diseases
  • Neuroscience
  • Oncology
  • Ophthalmology
  • Pathology
  • Rare Diseases, Pediatrics, Urologic and Reproductive Medicine
  • Active and Implantable Devices
  • Data Protection and Cybersecurity
  • Digital Diagnostics including Artificial Intelligence and Machine Learning (AI/ML) and CAD
  • Digital Medicine and Digital Therapeutics (DTx)
  • Imaging and Radiation Medicine
  • In Vitro Diagnostics (IVD)
  • Remote Patient Monitoring
  • Software as a Medical Device (SaMD)

Regulatory Services

Our regulatory experts develop comprehensive product strategies to help your product achieve market clearance in global markets. We leverage our deep understanding of the regulatory landscape to create and execute tailored strategies that guide your product through the critical milestones of product development and the approval process.

  • Submissions & Applications
  • Clinical Support
  • Regulatory CMC
  • Regulatory Labeling
  • Promotional and Non-Promotional Materials Review
  • Health Authority Interactions
  • Accelerated Regulatory Pathways
  • Regulatory Operations
  • Regulatory Program Management
  • Registration and Representation
  • Audit & Remediation
  • Support Services
  • State Licensing
  • Market Access & Reimbursement

Learn more about EVERSANA's Medical Legal Regulatory (MLR) services.

Contact Us

Contact us to learn how we transform data into actionable knowledge that informs decisions and reduces risk.