The company utilizes third-party manufacturers and Contract Research Organizations (CROs) to perform manufacturing and conduct preclinical and clinical studies. These third parties are required to comply with contractual and regulatory standards, including quality control and assurance. Noncompliance by these parties may delay or prevent the development, regulatory approval, and commercialization of the company's product candidates. The company engages CROs and consultants for the design, conduct, supervision, and monitoring of preclinical studies and anticipates continued reliance on CROs, clinical data management organizations, institutions, and clinical investigators for future clinical trials. All activities must adhere to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and regulations enforced by the FDA, EMA, and other regulatory authorities. As CROs are not employees, the company does not have direct control over their performance; failure by CROs to meet obligations or regulatory standards could result in unreliable data, additional studies, or delays.
Proqr Therapeutics N V's Comment on Supply Chain
The company utilizes third-party manufacturers and Contract Research Organizations (CROs) to perform manufacturing and conduct preclinical and clinical studies. These third parties are required to comply with contractual and regulatory standards, including quality control and assurance. Noncompliance by these parties may delay or prevent the development, regulatory approval, and commercialization of the company's product candidates. The company engages CROs and consultants for the design, conduct, supervision, and monitoring of preclinical studies and anticipates continued reliance on CROs, clinical data management organizations, institutions, and clinical investigators for future clinical trials. All activities must adhere to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and regulations enforced by the FDA, EMA, and other regulatory authorities. As CROs are not employees, the company does not have direct control over their performance; failure by CROs to meet obligations or regulatory standards could result in unreliable data, additional studies, or delays.
Sources:
Proqr Therapeutics N v 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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