Our team is composed of expert industry professionals for the Australia, New Zealand, Asia Pacific, United States, United Kingdom and Europe jurisdictions. We provide you with the highest quality support, practical help, and guidance through complex regulatory, quality, clinical and pharmacovigilance requirements. All tailored to your particular needs in the market(s) of your choice.
We exist to help you get medicines, to patients who need them, faster. It is our mission to give you dedicated, results-focused, strategic entrepreneurial and operational support.
We will work side by side with you and your team, making sure we are always on the same page. We are flexible, available at short notice, adaptable, and think creatively in order to achieve the best commercial outcome for you, your organisation and your patients.
We have both depth and breadth of experience in global Regulatory Affairs, Clinical Development, Quality and Pharmacovigilance across prescription (including biotech products, stem cells, blood products, vaccines, biosimilars, small molecules and generics), over-the-counter (OTC) and complementary medicines, medical devices and cosmetics. We excel in cutting edge product development, innovative registration strategies and health authority negotiations. We are also trusted partners for business as usual activities such as life cycle management.
Whether you need a new product registered or post market support, we employ multiple strategies to help you get to market faster. From our team’s expertise in product development, creativity, and innovation, to our knowledge of global markets, synergies in different markets, and worksharing across regulatory authorities. We leverage all that we can to provide you with the knowledge you require to get you where you need to be.