CMC Compliance

With over 25 years’ of industry-leading experience in the area, G&L Scientific is an expert at ensuring that our clients meet their ongoing CMC Compliance obligations – to manufacture and release products to market within the limits imposed by the approved regulatory documentation and local regulatory requirements.

Failure to ensure CMC compliance has led to healthcare companies incurring enormous financial costs (totaling billions of dollars) across penalties, litigation, brand perception, third-party controls, loss of stock value and product recalls. Portfolios of mature products, multiple databases, inadequate change control systems, reliance on third-party manufacturers and high levels of staff turnover are all significant ‘red flags’ and risks for CMC Compliance.