Regulatory Affairs

Regulatory Strategy:

A well-planned regulatory strategy is the foundation for successful product development and market access. At Agos Pharma, we collaborate with you to develop a Regulatory Strategy that aligns with global regulatory requirements. We design custom strategies for market entry and lifecycle management, ensuring that all necessary regulatory milestones are met efficiently. Our approach is pragmatic and flexible, enabling you to adapt to changing market conditions and regulatory demands.

Regulatory Intelligence:

Staying ahead of regulatory changes is critical for your success. Our Regulatory Intelligence services provide you with actionable insights into the latest trends, regulatory updates, and emerging guidelines in key markets. Agos Pharma tracks global regulatory developments, ensuring that your products are always compliant with the most up-to-date requirements. Whether you’re looking for insights into specific markets like the EU, US, or Asia-Pacific or more niche markets, we offer tailored intelligence to keep your development strategy on track.

Regulatory Project Management:

Effective management of regulatory submissions is crucial for on-time approval. At Agos Pharma, our Regulatory Project Management team provides end-to-end project management services, ensuring that regulatory submissions are completed on time and within budget. From initial planning to submission and approval, we can oversee every aspect of the regulatory process. We also offer oversight of third-party vendors and CROs, ensuring alignment with your strategic goals and regulatory requirements.

Gap Analysis / Scientific Data Assessment:

Is your current regulatory data package sufficient to meet submission requirements? Our Gap Analysis service helps you identify potential data gaps and regulatory weaknesses that could impact your submission success. Agos Pharma’s experts assess your scientific data, provide recommendations for data generation, and ensure that your product is positioned for successful approval. Our detailed Scientific Data Assessment reviews ensure that all necessary information is gathered, analysed, and presented effectively.

Health Authority and Notified Body Meetings:

Building strong relationships with regulatory authorities is vital for smooth approvals. At Agos Pharma, we assist in preparing for and managing Health Authority Meetings. Whether you’re seeking advice from the FDA, EMA, or other global authorities, we help you develop an effective strategy for engaging with key decision-makers. Our expert team ensures that you present your data clearly, respond effectively to queries, and shape regulatory strategies that support your market goals. Our in-depth knowledge, together with experience of current timelines and agency “sweet spots” allows us to advise you on the best agencies to approach for your product in order to maximise the benefit of your meetings.

Marketing Authorisation Procedures (MAA)/US FDA Filings

Registration is a critical step in the commercialisation of your product. Agos Pharma guides you through the relevant country or regional processes, helping you prepare and submit comprehensive dossiers that meet applicable regulatory requirements. Our team ensures that your submission is complete, accurate, and aligned with the expectations of health authorities, maximising the chances of approval.

We can also advise on how to adapt your dossier for one region to become acceptable for other regions, saving you time and money.

Paediatric Plans and Orphan Drug Submissions:

For medicines intended for paediatric populations or rare diseases, regulatory requirements are often more complex. Agos Pharma offers expertise in developing Paediatric Plans and supporting Orphan Drug Submissions and Designations. We help you to navigate the paediatric regulatory pathways and leverage the benefits of orphan drug status, including market exclusivity and incentives for rare diseases.  This can be valuable to your company, allowing access to reduced fees, market exclusivity and rare disease incentives.

Medical Device Regulatory Affairs:

Agos Pharma provides comprehensive Medical Device Regulatory Affairs services, from device classification to preparing and submitting technical documentation. We assist with device lifecycle management, including regulatory submissions, conformity assessments, and post-market surveillance. Our comprehensive understanding of medical device regulations ensures that your products meet the requirements of health authorities and Notified Bodies, streamlining the approval process.  We can also assist in review and preparation of documents for your Quality Management System to ensure compliance with relevant ISO standards.

Regulatory Training:

Our Regulatory Training services help your team stay informed on current regulatory practices, policies, and industry trends. We offer training on a variety of topics including drug and device regulatory affairs, clinical trials, good manufacturing practices (GMP), and good clinical practices (GCP). Our customised training programmes can be delivered on-site or remotely, ensuring your team is always up to date and compliant with the latest standards, directives and regulations.

Ad-hoc Consulting:

At Agos Pharma, we understand that each project is unique, and sometimes you need specialised support. Our Ad-hoc Consulting service provides flexible, expert advice for specific regulatory challenges. Whether you need assistance with a specific submission, regulatory strategy, or any other regulatory issue, we provide practical, actionable solutions to address your needs.

Post-Market Regulatory Services:

Regulatory compliance does not stop once a product is launched. Agos Pharma offers a wide range of Post-Market Regulatory Services, including pharmacovigilance, post-market surveillance, annual reporting, and regulatory updates. Our team ensures that your product remains compliant with evolving regulations, helping you maintain your marketing authorisation and ensure patient safety.

Marketing Authorisation Holder (MAH) Services/US Representative Services:

If you are aiming to market a product in Europe but don’t have a local presence, our Marketing Authorisation Holder (MAH) services provide a Bridge to Europe™. Agos Pharma can establish an MAH for you and oversee  regulatory obligations such as submission of periodic safety reports, pharmacovigilance activities, and compliance with EU regulations. We also provide support for medical affairs, quality assurance, distribution oversight, and reimbursement interactions, ensuring your product remains compliant in all key markets.

Similarly, if you require a local representative in the US for communication with FDA, we can provide that via our US-based consultant.