A small NE-based anti-infectives company pursuing an approval for treatment resistant UTI. They are approaching the latter half of their ongoing phase 3 and are looking to conduct a 10% audit of the likely FDA inspection sites. Of the 140 sites a good number of them have not actually enrolled patients, so the number of […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]
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Flexible clinical (GCP) quality consulting services for a period of approximately four to six months. Support activities include defined tasks such as those related to SOP development and implementation, and incidental/undefined tasks such as consultation on specific issues or events. Regardless of the specific services, all support and advice will be provided in accordance with […]
READ MOREI have a friend that needs a consultant with experience in preparing for Medical Device Single Audit Program (MDSAP) specifically for Health Canada and FDA. They already have a contract/agreement scheduled for a two-phase audit with InterTek Inc. and needs immediate help preparing for it. · Medical Device Single Audit Program (MDSAP) specifically for Health […]
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