Role of Regulatory Affairs in Product Development

Developing a pharmaceutical product is a complex and highly regulated journey involving various teams, including R&D, Clinical, and regulatory affairs.

Key Role in Project Initiation and Target Product Profile (TPP) Framing

Pharmaceutical companies decide on new projects based on an intended Target Product Profile (TPP) to frame the development of new products for their portfolio. A key aspect of this process is the input of the Regulatory Affairs Professional, as they are the ones responsible for advising on the prescribed information required for the proposed new medicinal product. This competency combines knowledge and experience in the particular market/geography and the target product class. In essence, most regulatory professionals have a basis of regulatory and market information at their fingertips and would have additional resources to supplement these repositories if required.

Post-selection of the TPP, regulatory affairs professionals listen to the product development strategy, challenge the assumptions, offer options and opinions, help define risk (including consequences), and holistically provide an objective reference for CMC, Quality and Clinical professionals before the initiation of development.

Early Involvement & Long-Term Benefits of the RA Team

The Regulatory Affairs team (RA) is key in delivering vital strategic guidance and technical advice on regulatory requirements for the product development team. Involvement in Regulatory Affairs at the early stages of product development is crucial and has long-term benefits. Critical attributes such as safety, purity, potency, and manufacturing consistency must be demonstrated. Constant interaction with regulatory authorities during product development is essential to discuss deviations from the guidelines, clinical study designs, product development designs, and related studies¹. Suitable standards evolve throughout the development process as knowledge about the product increases in the later stage of clinical studies when we use many doses².

Regulatory Affairs Professionals connecting the different stakeholders

Another key area where the regulatory team can support the product development team is regulatory documentation during product development, including scientific advice meeting packages, clinical trial applications and regional/country-specific requirements. These are all key criteria and processes that fall under the purview of the regulatory professional as they form the bridge among the stakeholders, including health authorities, the pharmaceutical company and even consumers.

Regulatory Responsibility in Marketing Authorisation and Life Cycle Management

The RA team is crucial in navigating the course of product development, getting marketing authorisation for innovative medicinal products being developed in the pharmaceutical company, serving as the point of contact with the regulatory authorities during the pre-submission, submission, and post-approval phases, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before granting the marketing authorisation.

The regulatory professional is also concerned with the later stages of product development. Marketing authorisation is maintained throughout the life cycle if the pharmaceutical company wishes to market the product. To achieve this, they have to carefully monitor changes to the regulatory requirements and guidelines referred to during the development of the product and the impact of the same during product registration and maintenance¹.

The Holistic Nature of the Regulatory Professional

As we can see, regulatory professionals are well-rounded individuals with knowledge from various disciplines throughout the pharmaceutical product lifecycle. They are key cogs in the machine, connecting multiple departments and providing invaluable support in developing the company’s product portfolio. The regulatory team must be knowledgeable in Market Access, Regulatory Information, Pre-Clinical and Clinical activities, Quality and Compliance, Chemistry, Manufacturing and Controls and Life Cycle Management procedures.

Get Your Regulatory Expertise Needs Met at ProductLife Group

experts in ProductLife Group have over 20 years in the industry and have supported clients with many aspects of Product Development and throughout all product lifecycle stages. Trust PLG when you require regulatory information and strategy on the market you want to explore, a product category you are developing, or whether you need support writing your clinical protocols. Our experts are available to review your dossier, publish it and support the post-marketing activities, such as Life Cycle Maintenance.

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References:

• https://www.pharmaceuticalonline.com/doc/why-you-should-engage-with-regulatory-early-in-product-development-0001
• https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs