Avoiding the Pitfalls that Can Arise During the Regulatory Submissions Process
At Accelagen, our Regulatory Affairs team are involved in many parts of the drug development process, including, the management of regulatory applications for companies who are seeking marketing approval in Australia, New Zealand, or other countries. This area is predominantly where Accelagen has its main interaction with regulatory agencies, based in our part of the world.
In Australia, our regulatory authority, the Therapeutic Goods Administration, have adopted many international regulatory guidance documents and standards,, but we also have some unique requirements to which we must adhere when making submissions.
Importantly with development and management of all regulatory submissions, it’s key to have someone available that understands and can provide a level of critical assessment of your data against those local requirements and flag any key challenges or areas where questions may arise. So that either one – we address them prior to submission or be ready to take on (and respond to) questions, should they arise.
What Makes Accelagen the Leader in Regulatory Submissions?
The team at Accelagen has that depth of experience that allows us to look ahead and help you avoid pitfalls commonly associated with certain areas – whether it be of potential gaps in the data where the authority will request additional information, or whether it be areas where improvements can (and/or should) be made. By providing a detailed assessment report to our clients, they understand the criticality of the issue(s) raised and the potential mitigations we suggest.
Similar to other jurisdictions, we have certain requirements that must be met to ensure an application is acceptable for submission. These mandatory requirements are often the minimum dataset needed for a successful submission. Part of our evaluation will identify these, which are important to flag early because without being able to address these key requirements, the application will not be accepted for evaluation. Because of its importance, this first and foremost becomes our baseline. From there, we work with our customers to prepare a submission that presents the data in a manner regulators can follow. It is important that they understand the product, its quality, it’s safety, its efficacy, and the data intended to support these aspects. And finally, the intended label claims that supports the overall commercial objectives.
Essentially, Accelagen takes the initial application, we review it against our local requirements, we identify any areas of improvement (or, in fact, mandatory changes) that will need to be made. Then we develop a thorough, correct, and detailed compilation of the data required for submission; and the team manages that entire submission process from lodgement to approval.
The best part about working with Accelagen on Regulatory Submission
Accelagen has an understanding of what is needed, but more than that – we truly have a regulator’s viewpoint, a longtime industry professional’s experience, and a customer’s desire to be successful.
We don’t just go through a guidance document ticking boxes – we work hard to present the data in a way allows regulators to immediately appreciate the benefits and areas of potential. Additionally, Accelagen can identify gaps and then apply pre-planning to those to make the process as efficient as possible.
Accelagen offers the right team, the right answers, and the right format.
Accelagen has an amazing regulations team and they enjoy working with our partners to create strong partnerships. We often have clients who come back over and over again in the regulatory space because our team is so passionate about what they do and so knowledgeable about how to do it. It really is about that long-term partnership piece for us.
Collaboration between all the parts of the process, supplemented by our additional services in-house – from medical to safety – combines to add greater value to the overall organization.
Just as important as what is being submitted, is the format in which it is submitted. In some cases, this may be electronic CTD publishing – which is another service Accelagen offers in-house, making the process more efficient.
Regardless of where you are… Accelagen has been there.
Often we have clients who have never done this before – or perhaps it is one of the only times that they may ever do something like this. We provide them with the confidence that their objectives are in safe hands.
Conversely, we also have companies that we’ve been supporting for 10 years or more, wherein we become their Regulatory Department. For these customers, we have become an extension of their team and we are able to support them overall. By having that long-term relationship, we have not only an understanding of what they need, but a history of the evolution within the company that allows us to aid in their growth and expansion.