Business continuity in Regulatory Affiliate Outsourcing throughout Covid-19

The Client

A multinational biopharmaceutical company with headquarters in Europe.

The Context

Several years ago, a multinational biopharmaceutical company began partnering with ProductLife Group to support maintenance activities through its regulatory affiliate model across global markets.

Client’s Challenge

• Initial:
  given the size of the project and the number of people
  and countries involved, major challenges were to ensure full oversight and successful execution of planned activities and to react quickly to the client’s ad hoc requests.
• Recent:
  a priority for the client has been to ensure maintenance activities continue uninterrupted amid the Covid-19 pandemic that has created disruption in many parts of the industry. Moreover, in recent months, the workload has increased, although unrelated to the Covid-19 crisis.

The most significant challenge for the client is the situation at the local health authorities, with some delays in responses, some not accepting certain types of dossiers, and general process slowdown as regulators struggle to deal with the shift from on-premise to remote working.

The client turned to PLG for regulatory affairs support in 30 European countries as well as Ukraine. The Central-Local Outsourcing Operating Model (Cl-O₂ model) is a unique service that puts PLG into tight collaborations with clients to execute clients’ local regulatory affairs activities in the framework of a project or program.

Those activities are:

• Handling of the variation process according to relevant European Union procedures
• Provision of local regulatory intelligence support in the forms of:

1. 1. Information on regional policies, such as fee changes, new guidelines, and new policies for processing Marketing Authorization Applications
   2. Procedures for submission in a specific country
   3. Changes to clinical trial requirements
   4. Processes for reporting shortages of or risks to the supply of key medicines
   5. Updates on support of the safe and effective use of medicines

• Management of the certificate of pharmaceutical product
• Creation and update of abbreviated product information
• Conducting of artwork reviews and linguistic reviews based on changes the client wishes to apply

Country email boxes where information is gathered, and which is monitored to ensure projects are picked up promptly.

Well-established work-from-home set up – processes, technology, and infra-structure are in place to enable PLG’s entire team to work remotely.

Business continuity standard operating procedures in the quality system that allow rapid response to any situation, not only for the Covid-19 pandemic, but to address any crisis situation.

PLG’s digital capabilities provide automatic reports on the Covid-19 situation across Europe, which is fed into a tracker and shared with the client.