REGULATORY COMPLIANCE
Selecting a partner that has the necessary regulatory expertise and experience is crucial to the success of every drug development project. CML has the experience, facilities and staff to provide the necessary oversight to meet your regulatory milestones. CML routinely contributes to IND, IMPD, NDA, and ANDA submissions, and have numerous approved Drug Master Files across multiple sites. Our exceptional regulatory history is a testament to CML’s hard work, and strong ties with numerous regulatory agencies. CML is regularly inspected by multiple regulatory agencies, and facilitate dozens of customer audits annually. CML ensures that any regulatory issues that arise are handled quickly and professionally.
In the early clinical phases, budgets are closely managed. A clear understanding of GMP and how it applies in the development phase is a core strength of CML. A pragmatic, risk-managed approach will save time and money, allowing our clients to get to key project milestones faster.
Regulatory Compliance Documentation
- Investigational New Drug (IND)
- Investigational Medicinal Product Dossier (IMPD)
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
- Drug Master Files (DMF)
- Management of GMP documentation and compliance procedures
Regulatory Compliance Audits
- FDA Inspections
- Other Regulatory Agency audits
- Client Audits
- Ongoing Internal Audits by CML Quality Assurance Team
Resources
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5 Centers of Excellence
CML is organized along five key integrated Centers of Excellence, providing our clients with end-to-end solutions.
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