PLG Meets Tight Regulatory Compliance Deadlines for Biopharma Client

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. 

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.