Drug Master File for a Drug Delivery Device Component #1:
A manufacturer of marketed device components holding an established Drug Master File determined that the DMF was in need of revision and reorganization to render it current and reviewer-friendly. Chimera, reviewed the DMF, identified information that could be eliminated and outlined revised organization of the remaining information. An interim DMF was drafted which did not require re-cross reference. Later, Chimera prepared product specific dossiers which were provided to customers for their products. The non-confidential customer specific information provided to customers was then removed from the interim-DMF and a new DMF was established which contained only proprietary information. Customers were then able to cross-reference a new reviewer-friendly DMF that was slimmer and easier for the component manufacturer to maintain. Chimera assisted in subsequent customer notifications and review coordination with FDA. Drug Master File for a
Drug Delivery Device Component #2:
A manufacturer of a device component for drug delivery devices which was based on new technology wanted to file a DMF to support US marketing and was in need of guidance on its content. Chimera worked with the manufacturer’s technical team to define the required content and advised the team by providing guidance and comments on DMF drafts. The DMF was finalized. The device component manufacturer submitted the DMF to FDA according to advice provided by Chimera. Chimera advised the device component manufacturer in establishing a system to assist customers with DMF cross-referencing activities.
Biologic Master File:
An ex-US manufacturer of a component of a biologic constituent part that was based on new technology wanted to file a Biologics Master File (BMF) to support clinical investigations and subsequent marketing of a novel biological therapy. Chimera worked with the component manufacturer and the US constituent part manufacturer in planning the format and content of the BMF. Chimera drafted the BMF. During the drafting of the DMF Chimera identified deficiencies in manufacturing process controls which were subsequently remediated. The DMF was finalized and transmitted to a CRO for electronic submission through the FDA gateway. Chimera serves as the manufacturers US Agent for BMF interactions with FDA.
Device Master File:
An ex-US manufacturer of a device component of a constituent part of a biologic-device combination product engaged Chimera to develop and produce a new Device Master File for submission to CDRH that described device component manufacturing and controls information. Following exchanges of drafts between the component manufacturer and Chimera the MAF was finalized and submitted to CDRH. Chimera serves as the manufacturers US Agent for MAF interactions with FDA.