Outsourcing Your Regulatory Needs
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Should you consider outsourcing your regulatory affairs needs?
Competing priorities, a lack of a particular specialism and resource or budget constraints are just a few reasons why you might consider outsourcing some or perhaps all of your regulatory needs. We understand this, which is why we offer regulatory outsourcing as one of our services.
“Competing priorities, a lack of a particular specialism and resource or budget constraints are just a few reasons why you might consider outsourcing your regulatory needs“
Moving into new markets…
You may be based in the US and looking for someone to support you in producing compliant labelling for an EU submission. It wouldn’t necessarily make sense to have a regulatory presence in Europe just for this task.
This is one example of precisely where we can assist, as shown in the testimonial below:
“As the leading experts in serialisation and traceability, Excellis were supporting a client’s rapid launch of a novel oncology product into the EU via the Centralised Procedure, across all markets to a highly ambitious timeline. In order to provide the client with the full expert support through a single point of contact, we subcontracted with Nik and his team to provide additional regulatory knowledge to coordinate and produce submission-ready labelling. Nik and his team were on hand to help with all aspects, available to turn around the client’s requests rapidly and based on their work, the client’s submission received approval. We couldn’t have asked for much more!“
Christoph Krähenbühl, Excellis Health Solutions
As your project evolves so do your needs
You may be entering or nearing the stage of your project where you really don’t know what regulatory support you may need. If so, you can rely on our experience and knowledge to help guide and support you in all regulatory aspects.
Grab a FREE, no-obligation 30 min call to discuss your requirements
with a senior member of our team.