Life Sciences is a highly regulated industry that prioritizes product quality and patient safety. The development of new typically takes an average of fifteen years, while patent protection for these products is often limited to twenty years. Regulatory authorities closely monitor the entire process from development to manufacturing. Noncompliance can result in delays in market approval or even product recall in cases of serious infringements.
Compliance with regulations is therefore of the utmost importance for companies in the Life Sciences sector.
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To achieve results within the often-changing regulatory framework, we help companies in Life Sciences to comply with all applicable regulatory requirements. Our OASeS framework provides regulatory gap assessments, implementation plans and support in remediation activities.