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LE4D LIMITED
Navigating the Regulatory Environment
About LE4D LIMITED
LE4Ding a world class full regulatory consulting service, focusing on efficiency, cost-effectiveness and adding value to companies. Our services span the length of your drug development journey, whether you are developing a medicine, device or ATMP. We support our clients every step of the journey. LE4D is operated by trusted experts within the industry. We were founded by Dr Zubair Hussain, who attained vast experience through senior roles within Pfizer, Ipsen and many more, but has vitally changed the regulatory environment whilst president of TOPRA. We partner with clients, providing the following tailored comprehensive services to navigate the regulatory and clinical environment: • Clinical Trial Application (CTA) • Regulatory strategy and gap analysis on the dossier • Marketing Authorisation Application (MAA) • Pharmacovigilance • Scientific Advice • Orphan Drug Designation Application • Paediatric investigation plans • Strategy • Risk Management Plans (RMPs) • New Drug Applications (NDAs)
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