Life sciences companies can end-up spending nearly one-third of their regulatory resources for the maintenance of products that are already approved and are in the market. These maintenance activities, which provide almost no competitive advantage but are critical to maintain sales, may restrict a company from putting its best regulatory resources for core competencies and innovations.
Today’s evolving healthcare landscape already poses many challenges to life science companies in terms of restructuring, consolidation, globalization, and budget cuts. Add to this the vast product portfolios of today’s life science companies covering numerous verticals and we get an operational landscape that is ripe with unprecedented challenges for survival. To compete effectively in such a scenario, life science companies are presented with the dire necessity to put more focus on core competencies.
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Companies are thus considering outsourcing of a number of non-core but highly critical processes, such as regulatory maintenance, as a way to address the numerous challenges and benefit from a variable cost model for regulatory maintenance abilities via an agile workforce. Regulatory outsourcing allows companies to apply a multidisciplinary expertise to their regulatory affairs and operations, thereby leading to reduced costs, improved processes, and accelerated approvals.
Increasingly Stringent Regulatory Requirements Lead to Rising Adoption of Regulatory Outsourcing
The stringent regulatory framework ruling the manufacturing, testing, and distribution landscape of drugs and medical devices across the globe is impelling life science companies to outsource regulatory affairs as a cost-competent and much effective tool for satisfying the diverse requirements of different regions. Currently, more than 70% of the world’s major pharmaceutical companies are outsourcing their regulatory affairs. This represents a huge growth over the past decade as regulatory burdens have increased. Companies may have a variety of reasons for regulatory outsourcing, such as more product launches than can be handled by internal teams. With the help of a regulatory outsourcing partner, companies can benefit from additional expertise that can be brought in as the need arises.
A research report published by market research company Transparency Market Research states that the global market for regulatory outsourcing had a valuation of US$1.56 billion in 2013. Developing at a 14.6% CAGR between 2014 and 2020, the market is expected to rise to a valuation of US$4.49 billion by 2020. The services of regulatory writing and publishing held a nearly 40% of the global regulatory outsourcing market in 2013, adds the report.
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Life Science Companies Need On-the-Ground Expertise to Survive in Regional Territories
The growth and profits of life sciences companies depend on their business in the international market. With the rising globalization, a need for a broader level of on-the-ground, local expertise has risen before the life sciences industry. Lucrative regional markets such as Brazil, India, China, and Russia come with their own individual set of rules. Even in the European Union, there can be 28 different sets of regulations according to each of its member states.
For efficient operations in such varying sets of regulations, companies need to appreciate the difference in cultures and bureaucracies, which can be a huge challenge for growing life science companies. This presents the need for regulatory expertise on local, regional as well as national levels. Outsourcing regulatory affairs to a trusted partner having a global footprint can make the task easy and add to the competitive advantage of the company.