3. Nuclear and Radiopharmaceutical Law (including regulatory)
development of radiopharmaceuticals is a highly regulated process that involves several stages, including preclinical testing, clinical trials, and regulatory approval. During the development phase, manufacturers must demonstrate that the radiopharmaceutical is both safe and effective for its intended use. This requires extensive research on the pharmacokinetics, biodistribution, and radiation dosimetry of the product.
Our roles in the industry involves a comprehensive approach to creating a functional, efficient, and compliant radiopharmacy, with a view to ensure seamless product access, regulatory alignment and sustainable revenue growth through targeted business development strategies.
As a nuclear and energy legal specialist practitioner, our Senior Director has over 17 (Seventeen) years in the legal field and over 7 (Seven) years’ experience as an advisor to producers & suppliers of nuclear medicine and radiation-based products in the nuclear, health and energy sector. He has been involved in negotiations, drafting or reviewing variety of commercial agreements such as sales agreements, distribution agreements, back-up supply agreements, irradiation services agreements, quality agreements with international back-up suppliers, partners, distributors and customer based in Belgium, Australia, Netherlands, New Zealand, United Kingdom, Poland, Japan and China, in the radiopharmaceutical or nuclear industry.
Having acquired knowledge and experience in the most niche field of law namely, Nuclear, Health, Science and Engineering, has empowered us with the most technical aspects of law and a broader knowledge in the most unfamiliar territories in the legal field and that has placed us in a more competitive and strategic position in comparison to most of our colleagues, in the legal field.