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Safe Strategy

The outsourcing bug hitting regulatory affairs (RA) is becoming more of a reality than the majority of RA teams think. Like other functional service areas, outsourcing in RA has its benefits as well as its downsides. Compliance areas like regulatory, medical or safety – which are generally risk-averse – tend to look to real-life examples from other companies in order to form their own strategies, picking what appear to be the ‘safest’ options.

The same situation exists for RA, and most firms are still trying to form an ‘outsourcing strategy’ which works for them. While this is being developed, because of financial pressures and growing work, some sponsors are resorting to more tactical outsourcing steps, involving components that are commoditised, such as publishing, or chemistry and manufacturing controls (CMC) writing for matured products.

When it comes to RA, every sponsor is different in terms of how they are structured, their product portfolio, their geographical reach and, more importantly, their risk appetite. This article will break down the components needed to help sponsors form their strategies.

Key Functions

RA’s main functions can be categorised under the following three areas:

Product Innovation
RA teams focus on ‘early’ approvals of new products − this involves regulatory intelligence, solid strategy and strong collaboration with cross-functional teams. For Big Pharma, this is still a ‘no-go’ when it comes to outsourcing, due to the complexity of department structuring which most large companies currently have.

In addition, because of intellectual property concerns, outsourcing in this area is not advisable. The better, and sometimes only, option is insourcing. But instead of taking a tactical approach with multiple staffing partners, narrowing down to two or three regulatory-focused insourcing vendors will help companies bring in the right talent faster and consistently, on both a local and global scale.

Customer Relationships
Health authorities and agencies are key RA customers, and any such relationship will be expensive and demand resources. As a result, companies currently have all sorts of combinations in this area – completely centralised, somewhat decentralised, completely decentralised – but, due to compliance risks of a product, headquarters often retain significant control of the submission process.

Unless the country or geography does not have the potential to add significant value to the top and/or bottom line, the customer relationship should be maintained by sponsors. Like running a relay, the first three laps can be performed by vendors, but the last lap of customer interactions should ideally be with the sponsors. Obviously, in situations where they do not have legal entities in specific countries, there is no option other than to depend on a vendor or partner for this task.

Technology and Infrastructure
How to tame technology still dominates the outsourcing discussions when sponsors decide on a strategy. For larger sponsors, different systems and databases are accumulated through mergers or acquisitions, and all of these hold information that companies need on a continuous basis for the foreseeable future. Most sponsors would like to take the bull by the horns when it comes to technology, aiming to solve its challenges ‘once and for all’. However, technology across the world is constantly changing, usually in a lifecycle of three to seven years. Therefore, where technology is concerned, the best suggestion may be to keep it simple.

Centres of Excellence

Most industries and the majority of successful companies have grouped best practices and ‘know-how’ into centres of excellence (CoEs). CoEs help retain knowledge, and ensure repeatability and sustainability by focusing on process-dependence, rather than people-dependence alone. Though RA is mainly people-driven, there are multiple areas of life sciences companies that can be knowledge and process-driven.

What goes into a CoE is mainly based on the type of products and location the company is in. Ideally, this should be led by a team or an individual who has extensive RA experience and, more importantly, can dedicate time to forming the initial charter and creating something tangible. It can be as simple as integrating best practices, or as sophisticated as providing tools and centralising regulatory intelligence and templates.


With the success of biotech firms, most of Big Pharma has ventured into biotech products, some in smaller formats and some very aggressively with high investments. This has led to healthy pipelines in the biotech sector, for both traditional companies and larger ones. Obviously, this has widened the gap between supply and demand of RA personnel for work on biologics, especially in CMC, among other areas. In addition, with the growth of biosimilars, the same types of resources are needed in this area, so it is important to supply the relevant portfolio with a separate resourcing model. In relation to biotech, some parts of RA can be outsourced, but this requires the management teams to commit to ensuring a strong, working outsourcing model.

Integrated Partners

Business process outsourcing (BPO) and IT firms have excellent processes and teams in place for publishing. If your strategy involves an outsourcing publishing component only, and nothing else in terms of RA for the next three years, it is best to use BPO or IT firms. However, should you need any CMC writing, lifecycle management support, or labelling and submission management assistance in the future, it will be difficult to rely solely on a BPO firm as these services do not align with their methods, which are more process and volume-orientated.

Specialised RA vendors offer all of these services but, of course, it is a mixed bag – some vendors execute these services better than others. Currently, most niche vendors do not have process maturity in all services across the board. If your needs are specialised, or some of your processes are small and need fewer full-time equivalents, such vendors can be well-suited as they offer flexibility and are likely to view your requirements with high importance. However, they are not without their downsides, as they may not take into account additional oversight costs.

With recent acquisitions of publishing technology, some IT and BPO firms have expanded their offerings to RA space in a more holistic manner. Integrated partners can bring many components together by minimising hand-offs and oversight burden, and bring value by leading your RA transformation − from technology through to process realignment. Once a steady state has been reached in an organisation, it is advisable to discontinue the collaboration in order to maximise return on investment and, as RA is a core function of life sciences companies, retrieve, to some extent, direct control on the delivery of services.

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Mahesh Malneedi co-founded MakroCare in 1996, serves as its President, and was instrumental in the company’s start-up and growth. He has 18 years of business experience, and holds an MS and MBA from New Jersey Institute of Technology.
Mahesh Malneedi
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