Expertise upgrade: outsourcing regulatory affairs in the pharmaceutical industry

05/07/2019 | Dr. Stefan Leyers
Leyers

Dr. Stefan Leyers
Associate Director Regulatory Affairs

Outsourcing certain tasks may be interesting for pharmaceutical companies of all sizes, for a variety of reasons. Companies often make use of outsourcing during transitional phases such as relocation, in urgent situations that can lead to an increased workload, or to cope with short-term understaffing due to employee illness or pregnancy, among other factors. But outsourcing can also pay off in the long term. Large companies can take advantage of outsourcing to reduce headcount and fixed costs for staff, whereas smaller companies that are unable to rely on economies of scale can turn to experts to take over duties that do not come up every day. What is more, companies of all sizes can benefit from the additional expertise that outsourcing offers.

Regulatory strategy

Outsourcing is often motivated by strategic considerations. For example, an external third party can ask authorities questions without influencing future market authorisation procedures or putting already approved products in jeopardy. When it comes to strategy, an external perspective on a project may offer fresh input and exciting new angles with the potential to save time and money.

An outside second opinion, based on experience in a variety of similar projects and knowledge of what authorities are looking for, can also support the decision-making process and help to persuade senior management.

The most important step in the outsourcing process is to choose a strong partner that can provide capacities at the right moment in time to ensure smooth onboarding. After that, it is essential for the service provider and the client’s staff to communicate appropriately and work with each other in order to make the partnership a success. Should you decide at any point to end the outsourcing agreement, the transfer of knowledge back to your company is a key responsibility of the service provider that can determine the future success of your work.

Life cycle management

In regulatory affairs, permanent outsourcing, as well as outsourcing designed to balance out peak workloads, often plays a role in life cycle management. Service providers such as Diapharm have the knowledge and experience to help companies avoid unnecessary variations, for example, as well as the resources (such as eCTD managers) to help save on expensive licences, allowing us to provide our clients with comprehensive, all-round support.

For international regulatory affairs, it is an advantage to have a service provider situated in the respective country, who speaks the national language and who can perform or correct translations into the specific language. This advantage of speaking the native language also makes communication and negotiation with the local authority much easier and more effective. Especially with a partner who has good relations with the authorities.  

Applicant

Diapharm is a fully qualified marketing authorisation holder and can therefore act as an applicant in national and international market authorisation procedures. The submission of authorisation requests by various different pharmaceutical companies can also help create duplicates in concerned member states, for example.

What is more, new marketing authorisations can be anonymised to prevent competitors from finding out in advance the manufacturer and brand behind a new product, giving our clients’ marketing experts valuable time to prepare advertising campaigns and product launches without the scrutiny of their competitors.

Full regulatory service

As a leading service provider and consulting firm, Diapharm offers a wide range of outsourcing options. From analytics to marketing authorisation, we are a trusted partner in the industry. Our experienced senior staff are influential throughout the pharmaceuticals sector and are there to support you with their expertise. Are you looking for a qualified person for pharmacovigilance (QPPV), an information officer or a qualified person for wholesale distribution? Then we are here to help.

We at Diapharm have extensive experience in working with our clients, plus we offer both flexibility and top quality. We care about the success of your project. Contact us!

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