Regulatory Outsourcing Scenarios

Regulatory departments within biopharma companies decide work with an external partner for one or more reasons,




Need for specialized expertise:

The specialized expertise and experience is quite often sought out due specific needs of the business. For example, need for a regulatory expert with experience in particular therapeutic area such as oncology, dermatology etc. Since the requirement to have the expertise could be short to mid-term, working with an expert consulting company/outsourcing partner can help. Similarly for operational needs such as publishing, artwork/labelling, in case the requirement is intermittent throughout the year, such work is outsourced


Geographic limitation:

Biopharma companies today are looking at global markets to maximize the value of their portfolio. Whether products under development or marketed products, going global is central to the most of growing companies. In such cases, regional regulatory expertise is required and more often it may not be a full time requirement. Considering the cost of hiring a full time resource and operational overhead of managing that resource, companies chose working with partner in an outsourcing model.


Focus on growth products and markets:

Companies with marketed products are increasingly realizing the need for their team to focus more on growth products and markets. Approximately 60% of internal regulatory teams’ time is consumed in non-growth activities such as license renewals, change coordination, data maintenance and updates. With a right partner in place, companies can off-load several activities and functions from different markets to a centralized or regional partner. This will help free-off internal teams’ time on focusing on growth products and growth markets with activities such as new product development, new products registration, key health authority interactions.


Cost saving:

The growing cost pressure on companies is leading the management to take measures that save more cost for the company without compromising on the quality of business. This is more so practical for companies with marketed matured products. Working with a partner can significantly help reduce operational overheads.


Increased workload:

Different business situations spike the workload for a sustained period. Regulatory leaders within the organizations need to assess the potential increase and put in place partners who could assist by sharing the workload while following the internal company SOPs and quality standards.


Corporate Strategy / Virtual Teams:

Companies following a virtual strategy outsource most of the regulatory work under directions of an in-house senior regulatory and strategic teams. Such companies have core business and strategy teams with most of the R&D and operations outsourced to third parties.

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