- Global Pharma News & Resources

Tips for a joined-up global approach to Regulatory & PV outsourcing

Tips for a joined-up global approach to Regulatory & PV outsourcing


Relieving local affiliates of heavy regulatory and/or pharmacovigilance workloads via a coordinated approach to outsourcing should be perfectly viable, but a frictionless global plan requires close coordination with HQ-level activities. Anna Lukyanova, COO of Arriello, offers advice on how to achieve a smooth transition.
  • Author Company: Arriello
  • Author Name: Anna Lukyanova
  • Author Email:
Editor: PharmiWeb Editor Last Updated: 06-Nov-2019

Speed of delivery, agility and cost-efficiency are high priorities in today’s competitive global life sciences market, so it is crucial that life sciences brands are not held back by their respective regulatory obligations in each country or region.

Yet this is exactly what can happen when there is a missing link between corporate HQ and dispersed operations or affiliates doing frontline work in local markets. Group head office can lose sight of the specific requirements in each territory as these evolve and change, as well as the ability to track how effectively these are being met. Meanwhile, teams may be duplicating processes –for instance collating, updating and checking information at both a global and a local level. As well as consuming resources that local offices can ill afford, this could introduce inconsistencies and errors because there is ambiguous ownership and stewardship of the overall process.

In the meantime many local market operations, especially smaller affiliates, are struggling to manage their time between routine compliance work, including regulatory filings and pharmacovigilance (PV), and their core remit – of growing the local business, conducting scientific work with local patient groups, and other day-to-day responsibilities.

As global regulatory and safety demands continue to grow more onerous and bureaucratic, this situation is becoming more acute. So how are global pharmaceutical and biotech brands adapting?

  1. Realising that something has to give.

The global life sciences market is subject to a sharp and steady rise in regulated requirements - around more detailed product reporting; greater transparency and traceability; and the proactive real-world monitoring and reporting required as part of ongoing patient safety/pharmacovigilance obligations. But who’s to say that this essential work must be completed by local teams?

Centralised coordination ensures that processes don’t become disjointed, that important steps aren’t missed, and that HQ isn’t left out of the loop if something changes or goes awry in a given market. It also makes it easier to roll out and replicate best practice, maximise resources, sharpen processes and accelerate delivery over time.

Meanwhile, as non-core activities shift to those with a helicopter view of what needs to happen, local experts reclaim valuable time to devote to the skilled work they are qualified and paid to do.

  1. Developing strategic relationships.

Outsourcing is still not used as extensively as it might be to bring closer alignment, coordination and consolidation of routine regulatory and pharmacovigilance work globally. Inertia, and the fear of immediate disruption, can keep too many firms tied to traditional ways of working - even if this is to their detriment. This short-sightedness could mean work is costing more than it should; tying up valuable resources; and risking process repetition, data duplication and error - because of inconsistent oversight, quality control, and application of supporting technology.

There are signs, though, that accepted norms are being challenged. Increasingly, we are seeing companies look to cluster their use of external services - offloading repeatable activities to a single outsourced service provider across a defined geographical region, for instance, or engaging a closely-linked network of partners coordinated via a strong single point of project management.

And initial pain soon gives way to considerable gains, with transitions to the external service provider usually possible within 3-8 weeks, depending on the complexity of the operations involved.

  1. Refocusing & re-energising key talent.

When global firms restructure their international regulatory/safety reporting, this is rarely from a perspective of wanting to cut staff. Rather, this is about refocusing skilled people’s time. Alternatively, internal teams could move across with the outsourced activities, to the service provider. Ultimately the aim is to improve process consistency, coordination and robustness, all of which is about making it easier to do a great job well.

Rather than each country team keep its own records of the latest local regulatory obligations, along with status information of where products are up to, for instance, the coordinating service provider can keep a definitive central record of everything, as it applies to each client/market/particular set of circumstances - a resource everyone can draw on with confidence.

  1. Avoiding a single point of vulnerability.

An optimised approach to outsourcing will generally involve consolidating project management at a single point, rather than creating new work in coordinating and managing different suppliers. Yet it is important too to have backup delivery options.

A good way to achieve this balance is to bring in a global service provider capability with a range of different partners in each territory, to arrive at the optimum overall service. It is rare for a single outsourcing partner to have its own direct facilities in 140+ countries, but a well-coordinated network of quality-controlled service providers, with a strong project lead, offers the best of both worlds.

The important thing is that resources are scalable and available on demand, and combine deep subject expertise with expert local consultants, all brought together via central project coordination.

  1. Keeping one eye on the future.

Last but not least, life sciences firms are realising the importance of adapting to changing requirements and circumstances. This is an industry where companies expand, merge, consolidate and change direction with regularity, with a knock-on effect on what they need. The same is true for service providers, of course, whose own commercial priorities may shift with evolving market trends.

So it is important to allow for evolution as part of service scoping, and focus as much on the cultural/relationship aspects of the new service contract as on the technical specifications of the immediate work that needs to be done.

A further consideration is the service provider’s roadmap for technology-led service innovation. From use of centralised document management systems, to real-time project management tools and at-a-glance dashboard performance/status displays, strategic application of software tools can transform global project coordination.

By paying attention to these five considerations, companies can hope to achieve greater harmonisation and extended cost-efficiency across their global and local regulatory and safety activities, whatever the future holds.

About the author

Anna Lukyanova is COO of Arriello, a provider of innovative, high-impact market access, regulatory Affairs & pharmacovigilance solutions and services for small to mid-sized biotech and speciality pharma firms.