DLRC Regulatory Consultancy
Ankita Jain is a seasoned business development professional with extensive experience in the life sciences sector, currently serving as Business Development Lead for Europe and the Middle East at DLRC Regulatory Consultancy since January 2025. Previously, Ankita held the role of Business Development & Partnership Lead (UK & EU) at HiTech Health, where significant achievements included partnership development and global customer outreach for a cGMP facility. Ankita also contributed as the Director of Global Business Development at Logomix, successfully leading global outreach and alliance strategies. Prior positions include Senior Associate in Corporate Strategy at 株式会社ヘリオス, Investment Associate at Saisei Ventures, and various roles in market research and project intern positions across notable organizations. Ankita possesses advanced education in bioengineering and biomedical engineering from The University of Tokyo and holds a bachelor's degree in biotechnology from Jaipur National University.
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DLRC Regulatory Consultancy
The pathway to market is complex but DLRC can simplify your journey. With well over 500 years of combined experience we provide a full range of Regulatory support from strategic advice in early development to compilation and management of Marketing Authorisation Applications and submissions throughout lifecycle. Since 2005 our innovative approach and collaborative interactions with agencies have helped secure approvals. We help companies of all sizes to maximise the commercial value of their products through carefully developed strategies and timely execution. We support development in areas such as rare diseases, respiratory, oncology, cell and gene therapy, medical devices, paediatrics and we specialise in helping Pharma and Biotech companies expand their portfolio into Europe. • Strategic advice • Scientific advice and agency meetings • Clinical Development • Orphan Drug Designation • Paediatric Development • Post Licencing Activities • Medical Writing • Publishing support for eCTD • PRIME designation application support • Marketing Authorisation Application Submissions • All activities specific to OTC medicines and generics • Risk management plans (RMPs) • Preparation of IND and NDAs • Regulatory compliance projects • Review of advertising and educational materials • Access EU/EEA SME incentives on behalf of SME clients based outside the EU • Due Diligence • Gap Analysis • SOP preparation • Change of ownership • Sunset clause submissions • Referrals • DMF reviews • Article 61(3) DLRC was awarded the Queen’s Award for Enterprise: International Trade 2017, and Herts Business Awards Employer of the year (winner 2016, finalist 2017/8) and Business Growth Award (winner 2018, finalist 2017). Our proven success comes not only from our Regulatory expertise, but also a collaborative approach and flexibility, providing inventive solutions to meet our clients’ requirements. Contact us to see how we can guide you on your Regulatory journey.