Regulatory Consulting

Experts in Evolving Life Science Regulations

Validant provides the seasoned guidance you need to effectively navigate complex regulatory requirements throughout the drug or device lifecycle. We empower you with perspectives, strategies, and tools to confidently progress down the right regulatory pathway, avoiding compliance pitfalls.

In fact, many of our partners and consultants have worked inside global health agencies, and we maintain close relationships with relevant regulatory bodies around the world to ensure accurate interpretation of current standards and to keep a pulse on what’s coming next.

Our Regulatory Practice offerings include:

  • Regulatory and Clinical Strategy
  • Lifecycle Management
  • Product Gap Analysis & Remediation
  • FDA/Agency Meeting Preparation
  • Face-to-Face Representation at Agency Meetings
  • IND, NDA/BLA, ANDA, IDE, 510(K), PMA Preparation

  • Submissions & Publishing & eCTDs
  • CMC Strategy
  • Advertising & Promotion
  • Drug & Device Labeling
  • Regulatory Affairs IT Systems
  • Investor Due Diligence
  • Project Management
  • Process Improvement & Implementation

Specialized in Regulatory Approval Pathways

Through our partner company, DataRevive, Validant clients have unmatched access to world-class regulatory expertise. DataRevive’s team includes a truly one-of-a-kind roster of former FDA CMC and clinical professionals and industry operators who are deeply versed in critical regulatory pathways globally.

They provide particular expertise in expedited pathways including Fast Track, Breakthrough Therapy, Orphan Drug Designation (ODD), and others.

Learn more about DataRevive’s consulting capabilities here.

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Case Study

Enabling Safe to Proceed Determinations from the FDA on Submitted INDs

See how DataRevive achieved a 100% passing of 32 IND applications over the course of one year.

View the Case Study

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Explore DataRevive

Specializing in Regulatory Affairs for small molecule and biological products as well as advanced therapies.

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We’re ready to help.

Through comprehensive regulatory consulting, we have empowered thousands of customers to efficiently navigate the life science product lifecycle from end to end. We’re ready to support you too.

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