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.

G&L Compliance expertise

G&L combines industry-leading regulatory affairs and CMC compliance expertise, with scalability and flexibility, working with complete discretion, confidentiality and collaboration with our clients’ multi-disciplinary stakeholders to deliver peace of mind through sustainable CMC compliance.

G&L is an industry expert in providing the full range of CMC Compliance services:

  • Advice and consultancy
  • CMC Gap Analysis
  • Data collection and collation
  • Adjudication
  • Remediation
  • Project management
  • Health Authority communication

“The G&L team works so closely with my team that I genuinely consider them as an extension to my team… Seamless!”Head of Regulatory Affairs, leading European Pharma company.

Contact us today

For more information on CMC Compliance, please fill in the form and we will respond to you as soon as possible.

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