Regulatory Affairs

Raland Technologies professionals are well-versed in regulatory requirements and can help you navigate through the process.

• Preparation & Review of Regulatory Submissions including INDs, CTAs, eCTDs, CTXs, IDEs, CTNs, NDAs, ANDAs, MAAs, BLAs, PMAs, and 510Ks
• CTM Services & Document Submission
• Document Control System Assessment
• eCTD Vendor Audits
• Review & Preparation of Drug Master Files (DMFs) and EDMFs
• FDA 483/Warning Letter/Consent Decree Response