Gene and cell therapies as Advanced Therapy Medicinal Products (ATMPs) have huge potential to more effectively treat previously intractable diseases. Successful development and commercialization of these innovations requires nuanced knowledge of the regulatory, compliance, and quality requirements of these complex products. Why Validant?
Validant’s team members bring a unique blend of industry knowledge – working with and for some of the leading gene and cell therapy innovators – and deep regulatory expertise from time spent within health agencies like the FDA. Together they possess expansive knowledge of the regulatory strategies and compliance, manufacturing, and quality systems required for these therapeutic modalities, and how they can best be optimized.
This enables us to support your gene & cell therapy from the earliest preclinical stages through to distribution.
Many gene and cell therapies can be developed via expedited pathways, including Fast Track, Breakthrough Therapy, and Orphan Drug Designation (ODD). DataRevive, Validant’s partner company, is comprised of former FDA CBER regulators who are intimately aware of the requirements for these regulatory pathways and how to tailor submissions to streamline approvals.
Beyond regulatory strategy, Validant also provides consulting and execution services to optimize GCP, GMP, and GTP quality practices and systems in line with FDA, EMA, and MHRA standards and guidance specific to advanced therapies.
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