Product Development to Achieve FDA Approval
Strategy & FDA Contact
Often, DDD is first engaged to help identify and develop regulatory and clinical strategies, and negotiate with the FDA to reach agreement on the approach. DDD documents agreements made between the FDA and the company in the meeting minutes. DDD amends the plans if needed.
Test Plans & Protocols
In collaboration with our clients, DDD develops test plans, writes the protocol including statistical based sample size and outcome measures, and places the studies at sites. An important role for DDD is the identification of qualified investigators who have the interest and experience to conduct the studies.
Clinical Monitoring & Auditing
DDD has personnel to monitor and to audit studies. The monitors check the accuracy of transfer of data to the case report form and compliance with the protocol (e.g., inclusion/exclusion criteria, informed consent, etc.). The auditors review the data for reasonable, for the choices made, and for the quality of the study, in terms of data acquisition and compliance.
Statistical Analysis & Evaluation
During the study, DDD enters the data into a customized computer program. Statistical analysis is performed to meet FDA requirements. DDD works with investigators to obtain a clinical perspective on study results. Then, DDD writes the statistical summary and incorporates it with the clinical report.
Quality System Regulations, GMP & GLP Audits
DDD provides expertise working with manufacturing personnel in developing standard operating procedures during the product development and scale-up phases. DDD also provides in-house audits of the manufacturing process giving companies a sense of the depth of an FDA inspection. DDD performs audits of contract manufacturing facilities and other vendors as needed.
FDA Meetings
DDD goes with (or in place of) the client to make presentations to the FDA. DDD works with the client and agency personnel to plan and prepare for the meeting: setting agendas, developing the presentation content and visual aids, submitting the meeting materials and rehearsing the presentation. DDD personnel take notes and write-up the minutes which document the conclusions and agreements.
Submissions
DDD specializes in developing marketing applications that are comprehensive, well organized, persuasive, and which anticipate FDA concerns. Our experience and skills include drafting, reviewing, editing, compiling, and submitting applications, including the cover letter. For devices, these include IDEs, 510(k)s, and PMAs. For drugs and biologics, these include INDs, NDAs, BLAs. DDD also prepares Technical Documents, Dossiers and Drug/Device Master Files (DMFs).
Often, DDD is first engaged to help identify and develop regulatory and clinical strategies, and negotiate with the FDA to reach agreement on the approach. DDD documents agreements made between the FDA and the company in the meeting minutes. DDD amends the plans if needed.
Test Plans & Protocols
In collaboration with our clients, DDD develops test plans, writes the protocol including statistical based sample size and outcome measures, and places the studies at sites. An important role for DDD is the identification of qualified investigators who have the interest and experience to conduct the studies.
Clinical Monitoring & Auditing
DDD has personnel to monitor and to audit studies. The monitors check the accuracy of transfer of data to the case report form and compliance with the protocol (e.g., inclusion/exclusion criteria, informed consent, etc.). The auditors review the data for reasonable, for the choices made, and for the quality of the study, in terms of data acquisition and compliance.
Statistical Analysis & Evaluation
During the study, DDD enters the data into a customized computer program. Statistical analysis is performed to meet FDA requirements. DDD works with investigators to obtain a clinical perspective on study results. Then, DDD writes the statistical summary and incorporates it with the clinical report.
Quality System Regulations, GMP & GLP Audits
DDD provides expertise working with manufacturing personnel in developing standard operating procedures during the product development and scale-up phases. DDD also provides in-house audits of the manufacturing process giving companies a sense of the depth of an FDA inspection. DDD performs audits of contract manufacturing facilities and other vendors as needed.
FDA Meetings
DDD goes with (or in place of) the client to make presentations to the FDA. DDD works with the client and agency personnel to plan and prepare for the meeting: setting agendas, developing the presentation content and visual aids, submitting the meeting materials and rehearsing the presentation. DDD personnel take notes and write-up the minutes which document the conclusions and agreements.
Submissions
DDD specializes in developing marketing applications that are comprehensive, well organized, persuasive, and which anticipate FDA concerns. Our experience and skills include drafting, reviewing, editing, compiling, and submitting applications, including the cover letter. For devices, these include IDEs, 510(k)s, and PMAs. For drugs and biologics, these include INDs, NDAs, BLAs. DDD also prepares Technical Documents, Dossiers and Drug/Device Master Files (DMFs).
