Case Study | Regulatory Compliance Deadlines for Biopharma Client

ProductLife Group helps client finalize regulatory compliance activities and improve processes

Customer context & PLG activities

The Client An Ireland-based multinational biopharmaceutical company.
Project description 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 initiates the gap analysis form (product name, countries, reference code).
RA consultant reviews the existing documentation and populates the gap analysis form.
If necessary, a second review is performed by another RA consultant.

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.

Project Scope

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.

Challenges

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.

Added Value

Customer benefits

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 success factors

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.

PLG Meets Tight Regulatory Compliance Deadlines for Biopharma Client

ProductLife Group helps client finalize regulatory compliance activities and improve processes

Customer context & PLG activities

Project Scope

Challenges

Added Value

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