Oxygen Life Sciences

Oxygen Life Sciences are committed to provide tailor made solutions to meet your Regulatory Affairs requirements. We have an extremely strong reputation for providing rapid, high quality Regulatory approvals and our strategies ensure smooth and efficient licence maintenance across all therapeutic areas. Our team have a comprehensive understanding of Global Regulatory requirements, along with a robust commercial awareness and ensure we develop the optimal Regulatory strategies required for the full Regulatory lifecycle. The long-term viability of your product is fully dependant on Regulatory developments. Oxygen Life Sciences can help you along the way by staying abreast of the ever-changing Regulatory environment. We do this by constantly obtaining new Regulatory information via our in-house capabilities and we consistently monitor health authority websites for any new developments from their respective National Authorities and official sources. We pride ourselves on providing tailored Regulatory solutions to meet the Regulatory Affairs needs of our clients, including ad hoc support for an urgent project need or a long term strategic programme to deliver Regulatory excellence with an experienced outsourced team. Oxygen Life Sciences are the only Regulatory Consultancy offering specialised in house Regulatory Translation Services and we also support eCTD publishing. Our clients range from the “Top 10” Pharma/Biotech companies in the UK to small one-man MAH holders and wholesale dealers as well as parallel importers. We are proud to offer the same level of service and commitment to any size of organisation. Our services include: