A developer of software used in electronic clinical data capture asked Chimera to make recommendations on regulatory pathway and software validation requirements to assure compliance with FDA regulations. Chimera advised the client on FDA requirements for software used to support regulated development and made recommendations on software validation requirements.
A pharmaceutical manufacturer wanted to change the design of the device constituent part of a prefilled delivery device. An s-NDA was filed for the design change. FDA issued a Complete Response Letter expressing safety and usability concerns. A Type C Meeting was established to discuss FDA’s concerns and provide responses to these concerns. Chimera assisted the pharmaceutical manufacturer in its preparation for the meeting by reviewing the Complete Response Letter and by providing comments on the meeting briefing document, which included a risk assessment and mitigation information and a human factors study protocol.
A device manufacturer sought pre-market clearance and labeling for specialized catheter intended for use in combination with a drug that was not labeled for an indication consistent with direct delivery to a target organ. Chimera assisted the device manufacture in drafting a Request for Designation to define the specialized catheter’s regulatory pathway to market.
A Pharmaceutical manufacturer developing an injection pen containing a two-chamber drug-diluent cartridge sought Chimera’s advice on establishing methods and specifications for syringibility force testing to be conducted during stability testing. Chimera assisted the manufacturer in establishing specifications and testing methods.
A biopharmaceutical company sought Chimera’s advice on structuring shipping validation and drop-testing protocols for a biological product contained in a novel autoinjector. Chimera drafted test protocols for the client.