Who we are
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.
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.
Vision
Remaining innovative is critical to our success. Oxygen Life Sciences strive to be the leaders in the industry by providing a one stop Regulatory Affairs consultancy service by delivering Regulatory solutions to companies developing products at the frontier of technology. We keep relationships with clients at the heart of everything we do and are experts in identifying skills and qualities in our team and match them to our client needs to create long standing and successful partnerships.
The Team
Anuj Malhotra – Co-Founder and Director
Anuj is Co-Founder of Oxygen Life Sciences. With over 20 years of Regulatory Consulting experience within the Pharmaceutical and Biotech arena gained partnering with some of the biggest names. Anuj has also successfully managed the regulatory outcomes some of the industries largest merger and divestment projects and also has a diverse regulatory background of lifecycle management across a large range of therapeutic areas. He has excellent rapport with senior management across the industry and has an exceptional reputation with many repeat clients and recommendations through “word of mouth”.
Anil Khedkar – Co-Founder and Director
Anil is a Co-Founder of Oxygen Life Sciences. Anil is a qualified pharmacist and with significant experience within the pharmaceutical industry that covers the complete product lifecycle, from early development to post marketing support. Working with multiple CROs and Consultancy Companies Anil has provided full clinical regulatory support from phase I to Phase IV . He has a very strong grounding in Regulatory project management and a real flair for balancing the commercial needs of a company with scientific data and regulatory ethics by working with multiple Pharma, Biotech and CRO’s.
Tahir Mahmud – Global Medical Information And PV Lead
Tahir is our in house lead for Medical Information and Pharmacovigilance Services. A pharmacist by profession, Tahir has over 10 years of extensive experience in this area having worked with Eli Lilly and GlaxoSmithKline and most recently supporting IQVIA with training and mentoring.
Azeem Shan - Consultant Qualified Person (QP)
Azeem Shan, BSc (Hons), MRPharmS, is an experienced EU Qualified Person (QP) based in the UK. A pharmacist by training, he has over a decade of experience in the manufacture, packaging, testing, and distribution of human and veterinary medicines, both as clinical trial materials and commercial products and also medical devices. Azeem has first-hand experience with setting up quality management systems, facility builds and expansions, New Product Introduction, training, performing audits of GDP and GMP facilities, and providing support with inspection remediation. His expertise covers EU GMP requirements, including successful MHRA and Veterinary Medicines Directorate inspections, along with experience with FDA pre-approval and GMP inspections along with several other international regulatory agencies.