.jpg/:/cr=t:0%25,l:0%25,w:100%25,h:100%25/rs=w:1209,cg:true)
RegulatoryEdge provides expert regulatory affairs, business development, drug safety, and medical information services tailored to the pharmaceutical, medical device, and cosmetic companies worldwide, with a specialised in depth focus on the Australian market.
At RegulatoryEdge, we understand the unique challenges and complexities faced by companies when entering Australian healthcare sector. Our approach involves partnering closely with our clients to navigate the intricate landscape of regulations and competition, ensuring efficient and successful product launches, and fostering sustainable business growth.
Our passion lies in transforming lives through facilitating access to quality medical care encompassing early detection and preventative measures, as well as various treatment modalities. With deep expertise in the Australian market and a global perspective, we are your strategic ally in achieving a future where everyone has the opportunity to live a healthy, fulfilling life.
Some of the specialised projects we are currently assisting our clients with are:
Our expertise extend beyond pharmaceuticals and encompass Prescription Medicines such as small molecules, biotechnology products and biologicals (e.g. faecal microbiota transplant, tissue-based and cell-based products), OTC - Over the Counter Medicines, Medical Devices and Cosmetics.
We work across strategy, R&D, operations, and commercial fields to assist our clients with challenges in areas such as:
We offer a wide range of services spanning regulatory affairs, business development, drug safety, and medical information for pharmaceuticals (small molecules and biotech products), biologicals (faecal microbiota transplant, tissue- and cell -based products) medical devices, and cosmetics. This broad expertise means our clients can get multiple needs met in one place.
We specialise in navigating the Australian regulatory environment, including TGA requirements for new product registrations in Australia, and establishing Australian affiliates/subsidiaries. This is crucial for international pharma companies entering the Australian market.
RegulatoryEdge is focused on value creation for clients, by aligning regulatory strategies with client business goals. We help clients create distinctive products and achieve growth in the Australian marketplace.
RegulatoryEdge offers bespoke services tailored to the unique needs of each client, whether it's customised medical information and drug safety services, process optimisation, or regulatory affairs coaching. We work closely with clients to transform their operations and human capital.
Our team of consultants assist with compliance with advertising codes, handling complaints, conducting regulatory affairs risk assessments, and developing mitigation strategies.
We offer unique regulatory affairs coaching to help clients achieve commercial goals and unlock innovative management approaches, as well as learn from results of mock audits and training programs for pharmacovigilance.
At RegulatoryEdge we offer clients option to leverage AI-assisted as well as fully human consultant expertise for medical writing, ensuring accuracy and efficiency. Our team stays up-to-date with the latest regulatory changes and industry best practices, providing clients with cutting-edge solutions.