Accelagen Offers a Full Suite of Regulatory Submission Management Services
At Accelagen, our expertise in regulatory submission management is pivotal for our clients in their drug development and marketing journey across the globe. Regulatory submission requirements are exceptionally important and may be invariably complex. A smooth and successful strategy requires an experienced and dedicated team to lead it, and Accelagen’s regulatory specialists are primed to provide our clients just that.
Regulatory strategy and management is an element of clinical development, and needs to be considered right from the outset of the product concept, and continues even after marketing approval. We regularly help our clients to design product development programs that will gather the right data to support approval of the desired claims, and once on the market, help to harness every opportunity to build a successful portfolio. If you have a regulatory question or problem – we can help!
While our core focus remains around prescription medicines, including biotechnology products, Accelagen also offers regulatory support for medical devices, instant delivery therapies, and other related medical products.
The complexities of regulatory management
One size does not fit all when it comes to regulatory management. Even subsequent programs from the same sponsors can require very different regulatory strategies, when considering key factors such as the target indication, drug classification and clinical stages. Our clients will have choices about the possible regulatory pathways along the journey, and we will apply our knowledge of the most successful approaches to guide each Sponsor to get the best outcome.
Another important decision that can affect the regulatory journey for Sponsors is the targeted marketing jurisdiction. While the requirements of Australia’s Therapeutic Goods Administration (TGA) and the European Medicines Agency (EMA) have many similarities, the Food and Drug Administration (FDA) in the United States may have alternative requirements for their submissions. Regulatory strategies need to consider the lifespan of a drug product so that future requirements from diverse regulatory agencies can be satisfied.
Accelagen is your regulatory advocate
Accelagen’s team of regulatory experts work as an extension of your team, and your representative to regulatory authorities around the world. We will bring our experience to help in designing the most suitable and efficient program to suit your needs. Depending on the complexities of your program, we may suggest a consultation directly with the Agencies early, where we lead communications and negotiations with such bodies, and evaluate opportunities for expediting the important steps to bring forward the time to have your product available for patients.
Leading the way through a complex web
We know that the regulatory submission process can be daunting and many of our clients come to us without a clear plan of attack. We are here to make that journey clear, starting with a gap analysis to highlight the specifications of their target market. Our team not only completes these tasks, we take the time to educate our clients from beginning to end. From there we work together to produce and execute a robust submission strategy, including regulatory strategy development, document preparation, risk management, authority engagement and submission.
We have an exclusive team dedicated to these highly-skilled tasks, with experience in the pharmaceutical and clinical industries. Many have worked for pharmaceutical companies and/or clinical facilities themselves. Our CEO has over 20 years’ experience in product development and the regulatory affairs field, instilling the principles of both into our operations. Together, we have the broad and deep knowledge base that helps tremendously with our clients’ regulatory submissions.
Even with all this experience, so much comes down to communication. At Accelagen, we devote ourselves to a level of communication with our clients where we explain what we are doing, and why we are doing it, with regular updates and check-ins along the way. The level of communication and understanding Accelagen has would be difficult to find in an organisation twice our size.
Whether you are a big pharma company, or a small biotech startup – you can benefit from Accelagen’s expertise, professionalism, and client-centered organisation. With clients in every continent, Accelagen really understands the challenges and needs of diverse organisations, as well as the guidance and regulatory demands for each. Most of our clients are regular and return clients. We have been collaborating with them for 5 or even 10 years – or more. They are what we call our permanent clients. We are very proud of our customers and what we’ve helped them achieve. We would look forward to you joining them!