Safety & Vigilance
Quality & Compliance
30 august 2021
An Ireland-based multinational biopharmaceutical company.
PLG prepared a gap analysis document for each product (tablets, creams, injections) and for several countries (predominantly Russia and countries in Europe), adopting the following processes.
RA assistant finalizes the document and saves it on the relevant repository
Risk factors and requirements
With projects of this nature, it is essential to start with an initial meeting that explains the process in order to ensure its smooth and efficient handling.
It’s also important to start with a pilot phase that allows processes to be adjusted if necessary and to ensure production gets managed smoothly.
Depending on the product and the regulatory documentation, a gap analysis document could be completed within 4 to 12 hours.
PLG was asked to finalize regulatory compliance activities in line with the client’s in-house processes.
The PLG team consisted of three regulatory affairs (RA) consultants, two RA assistants, and a project manager.
The team worked off-site, accessing the client’s documentation through a virtual private network.
The client’s team comprised two RA coordinators.
During the project, PLG reviewed 81 chemistry, manufacturing,
and control (CMC) marketing authorization files within the reference dossiers and prepared the corresponding gap analysis.
One of the challenges with a project of this scope is meeting the client’s tight timelines. Because of the urgent nature of the project, a very short pilot phase was implemented to familiarize the team with the client’s processes and expectations.
Another challenge was managing documentation held in different countries, much of which was very old, incomplete, unclear, and in different languages.
PLG enabled the client to complete a large volume of gap analysis of marketing authorization files under very tight timelines as requested by the Irish Medicines Board. In addition, PLG helped update the client’s processes for future activities, producing more than 30 gap analysis documents by the end of the first assignment.
During the four months of the project, PLG handled 110 gap analysis documents for the client.
PLG’s CMC and RA consultants are experienced — and accustomed to managing complex off-site contracts. Consultants who specialized in process and project management and who prepared the project contributed to its success.
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