Biologics Consulting Services

The development and manufacturing of these complex modalities can be very challenging, and requires the right regulatory, quality, and compliance expertise to successfully navigate through their approval and commercialization. Why Validant?

Scientict Making Research In Lab Analyzing A New Virus. Corona Virus Concept

Diverse Experience Across Modalities

Validant’s subject matter expertise in global regulatory, compliance, and quality requirements for biologics spans:

  • Monoclonal Antibodies
  • Enzyme Replacement Therapies
  • Biosimilars
  • Cellular- and Gene-Based Therapies
  • Tissue-Based Therapies
  • Vaccines
Diverse Experience Across Modalities

Versed in Global Standards for Regulated Biologics

Our team is comprised of former leaders of pharma and biotech companies that are spearheading the advancement of biological products, as well as former regulators from the FDA’s CBER.

Together we provide scientific, technical, and strategic direction, in lockstep with the latest global regulatory standards and guidance, for all phases of biologics development and commercialization.

How can we
help you?

Tell us what you’re looking to achieve.
We’ll put our experience to work on your specific problem.

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