Imagine this. You’ve been working on a drug project for years and you’re at the top of the game when it comes to the details of and science behind the drug itself. Now, without the proper regulatory strategy (i.e doing the right things at the right time), your project is at serious risk of not gaining regulatory approvals meaning that at the end of the day, patients will not receive the help they need in the form of your intended treatment. Or they will not receive it in time. Remember, one mission of the regulatory authorities is to ‘’foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health’’. In other words: in the interest of the patients, regulatory authorities want you to interact with them and ask for advice. The question is which body you should approach when, and how.
Our services within Regulatory Affairs make sure you to decrease the risk of failing or unnecessary delays. We also evaluate any possibilities for ‘’expedited pathways’’, a technical term for various regulatory fast-tracking possibilities intended to significantly reduce time to market.
Regulatory Strategies & Regulatory Intelligence
There are several kinds of regulatory assessments and all of them involve regulatory intelligence and strategies. The tools we use are described below.
Target Product Profile Workshops
A target product profile (TPP) document describes where you wish to go with your product, and how it can be differentiated from competitors. From a scientific viewpoint, it might seem odd to ''begin with the end''. But if you want your product to reach patients, it’s a good idea to outline the desired profile and characteristics of the target product and which disease(s) and patient population(s) the drug is aimed at. While not being a mandatory document per se, the TPP is highly useful and can be used also to facilitate dialogue with the authorities. SDS offers TPP workshops where we help you to define desirable label claims and evaluate alternative indications for your product.
A regulatory roadmap is a powerful strategic document that identifies and summarizes the ''drug route to market''. At the end of the document, you will find a list of recommendations from SDS Life Science. These recommendations can for example include:
- Regulatory strategy and legal basis for registering the proposed indications
- Potential expedited pathways and/or conditional approval strategy
- A communication plan for scientific advice meetings and other kinds of interactions with authorities.
- Plan for pediatric studies.
- Possibilities for data exclusivity and patent extensions.
Gap Analyses and Due Diligence
A gap analysis identifies any missing pieces or elements in the drug development program and fills those gaps with specific action items. At its core, the purpose of a gap analysis is to assure that you got things covered. By evaluating possible gaps, SDS Life Science can advise you on the adequacy of your non-clinical, clinical and quality packages and if they´re up to par with the demands from regulatory authorities.
Due diligence is essentially a version of a gap analysis but from a different perspective. A due diligence process evaluates OTHER companies and projects rather than your own. Gap analyses are done by the developers of a company or project and a due diligence analysis is done by the buyers to ensure a successful acquisition.
Due diligence and gap analyses are two sides of the same coin.
Communication with Regulatory Authorities
Discussions with regulatory authorities can be held at any time of the drug development process. National European authorities, EMA, FDA and PMDA (Japan), for example, offer different kinds of scientific advice meetings to respond to specific questions by the drug developer. The questions can relate to the pre-clinical, clinical and quality aspects of the development project. It’s all about optimizing the opportunities for advice and getting on the same page with the regulatory bodies.
Preparation and interpretation are key when communicating with regulatory bodies. SDS helps with defining questions to ask, preparation of the briefing document and meeting presentation, and organizing meeting rehearsals together with the drug developer. After the meeting, we help you to interpret the responses from the regulatory bodies and identify the next steps.
Preparation and Coordination of Submissions
Setting strategies and writing TPPs is one thing. Doing the actual work is another. we can support you in preparing documents, compiling submissions and coordinating the review process. The pre-submission activities include for example pediatric plans (PIP/PSP), requests for Orphan Drug Designation, Fast-Track and Break-Through Therapy Designation, PRIME. We also prepare eCTD submissions for Investigational New Drug Applications (IND) in the US, and Marketing Authorization Applications in the EU (MAA) and US (NDA/BLA).
What happens at our first meeting?
At our first meeting with you, we will do a basic analysis of your needs and where you are in the project. The intention with these meetings is to understand your need for strategic assessments and recommendations and whether you also need operational support. The initial meeting is also a splendid opportunity to ask a regulatory expert any questions you like. This is the first step towards sending you an initial draft of a business proposal.
The first meeting is completely free of charge. So don’t hesitate to send us an email or give us a call.