Regulatory Contract Staffing for a US Based Biotech Company

Artixio provides expert regulatory staff on contingent and contract basis to pharmaceutical and other lifesciences industries using both its in-house teams as well as network of thousands of regulatory professionals with experience in regulatory affairs, eCTD publishing, labelling, regulatory information management and other areas. This case study outlines one such example where Artixio is helping a biotech company based in the USA with its contingent regulatory staffing requirements.


Client:

Client is a specialized biotech company focusing on development of new drugs targeting rare diseases


Problem Statement:

The Company is approaching its timelines for IND submission for its lead drug candidate and required to scale its regulatory affairs and operations staff to meet the upcoming work load. The Company intended to deploy resources on mid-term basis and assess over a period time to recruit those resources full time.


Artixio’s Solution:

Artixio’s global team and network includes specialists experienced in US FDA regulatory affairs with diverse experience, clinical and non-clinical writing, eCTD publishing and regulatory information management. Artixio’s team worked with Company’s regulatory leadership to identify the key skills and experience required to develop a job description (JD). The JD was run through Artixio’s in-house resource pool to identify a suitable match for a candidate. The assessment was extended in Artixio’s pool of resources to shortlist potential candidates for proposed roles. The shortlist of candidates were qualified in the first stage by Artixio’s expert regulatory professionals based on the Client’s expectations. This resulted in significant time saving for the Client to de-clutter and focus on most potential candidates for further evaluation.


Outcome:

Client was able to select and deploy suitable candidates for Junior and Managerial role across regulatory affairs, eCTD publishing and regulatory information management roles within 3 months.