Regulatory Responses: Formal replies to inquiries or requests made by regulatory authorities, typically during the review process of a regulatory submission such as a New Drug Application (NDA), Biologics License Application (BLA), or medical device application. These responses are critical for addressing concerns, clarifying information, and demonstrating compliance with regulatory requirements.

Common Technical Document (CTD): A standardized format is used for regulatory submissions across different regions, including modules on administrative information, quality, non-clinical study reports, and clinical study reports.

Marketing Authorization Application (MAA): Used in the EU to seek authorization to market a drug, similar to the NDA/BLA in the US.

Pharmacovigilance safety reports (DSURs, PSURs, PBRERs, PADERs): Documents any adverse events or side effects experienced by participants, which are crucial for assessing the safety of the investigational product. Include safety updates, adverse event reports, and annual reports required to maintain market approval and monitor ongoing product safety.

Pre-Submission Documents: Initial communications with regulatory agencies, including meeting requests and pre-IND (Investigational New Drug) or pre-IDE (Investigational Device Exemption) consultations.

Investigational New Drug (IND) Application: Required for new drug products. It includes data from preclinical studies, clinical trial protocols, manufacturing information, and any preclinical and clinical study results.

New Drug Applications (NDA) or Biologics License Application (BLA): Submissions for market approval of new drugs or biologics, containing comprehensive data on clinical trials, efficacy, safety, labeling, and manufacturing processes.