Reliable Regulatory Submission Management Services from Accelagen
Navigating regulatory submission processes can be complex, especially when dealing with diverse global requirements. At Accelagen, we specialise in providing comprehensive regulatory submission management services, ensuring that your products—whether medicines or medical devices—meet the necessary requirements for market entry and continued lifecycle management across various jurisdictions.
Global Expertise, Local Focus – from Accelagen
Accelagen has significant experience working with clients across different regions, with a primary focus on Australia and New Zealand. However, we’ve also worked with clients from the US, Europe, and Asia, helping them navigate regulatory requirements for their products at various stages of development, from preclinical trials to post-marketing activities.
In Australia, our regulatory submission services primarily involve Category 1 submissions, which encompass the entire process of obtaining marketing authorisation. This includes registration, post-market surveillance, and addressing ongoing regulatory obligations such as safety reporting and dosage maintenance, particularly in the area of Chemistry, Manufacturing, and Controls (CMC).
Comprehensive Services Tailored to Meet Your Needs
Our services go beyond just the preparation of documents. We take a strategic approach to every project, ensuring that each submission is crafted to meet the specific requirements of the target market. This approach is particularly beneficial for clients who are unfamiliar with local regulations. Accelagen works closely with clients to perform gap analyses, identifying what is required for a successful submission, and crafting a strategy that suits their particular needs.
These strategies may include:
- Preparing dossiers, especially Module 2 documentation, and supporting documents such as risk management plans.
- Providing expert advice on regulatory strategies, including orphan drug designations and the preparation of meeting briefs with regulatory agencies like the TGA.
- Facilitating meetings with the TGA and other agencies, ensuring that all relevant information is presented clearly and accurately.
- Offering post-market support, helping clients manage any safety concerns or regulatory updates as needed.
Bridging the Gap Between Different Regulatory Systems
Every country has its own unique regulatory framework, and Accelagen’s team is adept at understanding these differences and helping clients navigate them. For example, in some cases, clients from countries like Japan may face difficulties when translating their regulatory dossiers into formats acceptable in Australia or other markets. Accelagen’s team is highly skilled in handling these challenges, providing not just translation services, but also scientific justification and strategic advice to ensure that the dossier aligns with Australian regulatory expectations.
Our experience working with diverse international clients has allowed us to fine-tune our approach and offer tailored solutions, whether it’s for pharmaceutical companies or smaller biotech startups. We guide clients through the entire process—from initial product development and clinical trials to commercialisation.
Experience That Sets Accelagen Apart
Accelagen’s team has years of experience in the regulatory affairs field, with a solid background in both the pharmaceutical industry and clinical trials. Our team members have previously worked with large organisations such as CSL, which provides us with a unique blend of regulatory and clinical expertise. This allows us to offer services that are not just about document preparation, but also about strategic planning and operational excellence.
With a team that includes in-house experts from various departments, such as CMC and clinical trials, Accelagen is able to provide a holistic approach to regulatory submission management. We understand that regulatory affairs are not just about compliance—they are about ensuring that your products reach the market efficiently and effectively, making a positive impact on patients’ lives.
A Proven Track Record of Success
Our clients consistently return to Accelagen for subsequent submissions, thanks to the experience, expertise, and trust we’ve built over the years. In fact, many of our clients have been working with us for over five years, recommending our services to others due to the quality and thoroughness of our work.
For example, we worked with a Japanese client on their submission to the Australian Therapeutic Goods Administration (TGA). The process involved translating complex dossiers, ensuring they met Australian requirements, and working with the client to navigate the differences between Japanese and Australian regulatory systems. Despite the challenges, our team successfully helped the client submit their dossier for evaluation by the FDA, with all three of their submissions ultimately accepted.
Supporting Clients Throughout the Product Lifecycle
Accelagen’s flexibility allows us to support a wide range of clients, from large pharmaceutical companies to emerging biotech startups. We understand the unique challenges faced by organizations at different stages of development, and we tailor our services to meet the specific needs of each client. Whether you’re in the early stages of proof-of-concept development or ready for commercializing your product, Accelagen provides end-to-end support.
From pre-market strategy development and regulatory submission to post-market compliance and lifecycle management, we help our clients achieve the best possible outcomes.
Why Choose Accelagen…
What sets Accelagen apart from other regulatory submission providers is our deep industry knowledge, personalised service, and commitment to delivering results. Our diverse team of experts has years of experience, and we take pride in offering practical, actionable advice that guides clients through the regulatory maze.
If you’re looking for a partner to help you navigate the regulatory submission process with confidence, Accelagen is here to provide the expertise and support you need. Whether you’re submitting a product for the first time or managing ongoing regulatory requirements, Accelagen is ready to help you achieve your goals and bring your products to market efficiently.
For more information or to discuss your regulatory submission needs, contact us today!