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Dianne Lee Email
Managing Director . DLRC Regulatory Consultancy
Letchworth Garden City,
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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.DLRC Regulatory Consultancy Address
Exeter HouseLetchworth Garden City, null
United States