Regulatory Strategy For Drug Development
Altus’ Regulatory Strategy and Submission Planning
Regulatory intelligence and regulatory planning are essential to efficient and cost-effective product development. Regulatory planning means more than reading the guidance.
Altus provides a full range of regulatory planning and execution services from initial regulatory assessment, through, IND enabling study planning, dossier development and submission, clinical submission meeting planning and in-person support.
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Why have a regulatory strategy for drug development?
At many points during its development, a new pharmaceutical drug will need to be approved by regulatory bodies, such as IND submissions prior to clinical trials or NDA/BLA to name a few. Taking into consideration the quality requirements made by the FDA, EMA or any other regulatory bodies in the target region is key to avoiding costly and time consuming regulatory failures. Basing the development strategy of a new drug around the quality requirements made by health authorities increases the chances of the new product being approved and making it to the market.
An effective pharmaceutical regulatory plan is continually edited and updated. It is a planning document that traces key events as well as summarizes critical development setbacks that would impact the cost and time. This document also tracks and records all of the key agreements that are made by the health authorities.
What should be included in a regulatory strategy?
To guide themselves through the development process, pharmaceutical companies and CMOs need reliable information and a preferred pathway to the market. In order to adopt the right strategy, they have access to the regulatory guidelines offered by agencies such as the FDA and EMA, as well as previously developed drugs. The optimal approach to obtain regulatory approval can be determined based on this information to ensure fast and safe commercialization. Analysing similar drugs and their development can also be helpful for a company’s regulatory strategy by discovering different requirements that might apply to their new product.
The regulatory strategy should also include a detailed guideline of key stepping stones on the drug’s development process. Such instances could be fillings such as IND submission, but also interactions with regulatory agencies at different phases of the process. Being prepared with the relevant data allows you to properly address the potential concerns of the agencies and avoid costly and time consuming roadblocks in your development.
The regulatory challenges of the pharmaceutical industry
Understanding the evolving regulations surrounding the development of a new drug is a tedious and complicated endeavour. With multiple health authorities quality requirements to consider, such as the FDA and EMA, creating a regulatory plan requires extensive knowledge of the industry and its practices, especially in growing global markets.
Their input is crucial to the development teams of a new product, as they will need to align both the product and its processes to the current regulations to ensure a high quality product and approval. Interactions with the relevant health authorities is also a complex task, where experience and knowledge can have a great impact on getting your drug to the market. This is why a reliable third-party such as Altus Drug Development can be a great option for your regulatory strategy.