Navigating the regulatory approval processes is an essential step on the Drug Development journey, getting this right leads to the fastest and smoothest development. Through every stage one needs to provide an appropriate submission that shows that the quality of the product is suitably controlled and so will secure approval but also provide flexibility needed for a robust supply of your Investigational Medicinal Product.
The team at Seda have extensive experience of authoring and review of the CMC modules of regulatory submissions at all stages of development and across all the main global markets. We also have specialist CMC Regulatory consultants (including an ex-MHRA Assessor) available for deeper reviews and development of the overall regulatory strategy.
We apply a phase appropriate approach. In the early phases of development, we can help you to design the experimental program to deliver the data required for your First in Human application and author the application to secure approval balancing the need to demonstrate suitable quality without overly constraining the manufacturing process in these early days of development when limited data on the product exists.
As you proceed through the clinical phases, we can help to ensure that your CMC data package develops to meet the growing expectations of the regulatory authorities with regard to data and understanding of product quality. We pragmatically apply Quality by Design approaches and specifically the development of a holistic Control Strategy that will become the cornerstone of your Marketing Application.
For many products the dissolution test will be an important element of the control strategy and justification of this test and ideally the development of clinically relevant dissolution specification (CRDS) is a topic of great regulatory importance. Seda experts have extensive experience in the development and justification of dissolution test and specifications and are recognised world leaders in the field of CRDS.
Seda can also guide you through your interactions with Regulatory Agencies including development of Questions and Briefing materials, team preparation, and representation of Clients at face-to-face interactions.
Why choose Seda?
The Seda team have taken more than 15 products right through the development process to commercialisation and can guide you through every step of the way. The leadership team have long been recognised as influencers in evolution and modernisation of global regulatory guidelines, in particular in the development of the Quality by Design initiative and the establishment of clinically relevant dissolution methods. For example, Drs Stott and Dickinson have been active members of numerous Industry : Agency initiatives such as FDA QbD Pilot Program, PQRI, etc and have published extensively in this field.
