An effective regulatory strategy is key to market approval.
One of the most overlooked aspects of product development is ensuring you have a viable regulatory strategy. Guidelines and regulations in different countries are continually changing. Keeping up to date and developing a plan of action based on the most recent regulatory precedent maximizes your chances of regulatory approval and ensures you do not miss an opportunity to streamline your development by taking advantage of the select programs offered by the different regulatory bodies.
GLOBAL REGULATORY EXPERIENCE
Experience is everything when it comes to regulatory success.
B4D has experience in all major regulatory jurisdictions (Canada, US, Europe) and has had continuous success with meetings and submissions to the various branches of the different agencies in those countries.
We provide all the necessary regulatory templates and experience preparing the components required for regulatory filings in the different jurisdictions.
B4D has established a network of experienced experts in CMC, quality, toxicology, clinical and statistics who can be utilized as needed for input into submissions or in assisting in negotiations with regulatory authorities.
Service 4: Regulatory
The first step is to identify the most effective regulatory pathway based on your product and chosen indication. We will identify the major market countries where approval will be beneficial to your marketing or licensing strategy. We will identify any expedite programs or regulatory incentives that may apply and carve out the best regulatory pathway based on your product’s stage of development and current funding.
We will address which regulatory authority might be best to seek guidance from first and at what stage in the development process would be most beneficial for a Pre-IND or Pre-CTA meeting. We will also plan subsequent interactions with the select authority and when it would be most advantageous to approach multiple regulatory jurisdictions. Our team can work with you to approach the selected regulatory authority for consultation on your product development strategy early on. This usually takes the form of a Pre-IND or Pre-CTA meeting request.
By analyzing both market approvals and the development landscape for your chosen indication, our team will use the most recent regulatory precedents in developing a regulatory strategy that has proven success while incorporating any unique advantages that may be inherent in your product.
Our team can write the documents that are required for the submission of the Pre-IND or Pre-CTA meeting requests as well as the IND and CTA submissions themselves. We will work with you to create the dossiers necessary for regulatory submission and ensure that all supporting documentation such as preclinical reports, CMC documents, investigator brochures and protocols meet regulatory quality standards.
As the development of your product progresses, we will ensure that regulatory milestones are aligned with the completion of significant development milestones. This will ensure that the regulatory authorities are kept current on your development’s progress and will make sure to take advantage of all available avenues of dialogue with the authorities.