In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission, including poorly organized information, incomplete stability data, and inconsistencies in the Chemistry, Manufacturing, and Controls (CMC) section.
Recognizing that its expertise in this area was limited and that deadlines were looming, the company engaged regulatory affairs consultants to support it in addressing these issues.
The resubmitted dossier earned an approvable letter thanks to its meticulous reorganization, strategic compliance updates, and expanded analyses. In this instance, the company salvaged its product’s market potential by working with consultants.
This example case highlights that the complexities of regulatory submissions require specialized expertise to navigate effectively. By outsourcing submission content development to regulatory affairs consultants, biotech and pharmaceutical companies are able to better reduce risks, streamline processes, and accelerate approval timelines.
This article explores some of the reasons why engaging these experts offers a vital strategic advantage.
Image Credits: Gorodenkoff/Shutterstock
1. Expertise in regulatory nuances
Regulatory requirements differ considerably between agencies. For example, agencies such as the FDA, EMA, and Health Canada each enforce specific guidelines for Good Manufacturing Practices (GMP), data integrity, and pharmacovigilance.
Regulatory affairs consultants have typically spent years working within these frameworks, affording them a wealth of knowledge in this area.
The eCTD (electronic Common Technical Document) format is mandated for global submissions, for example, and a good consultant will ensure that submissions maintain global standards while simultaneously adhering to region-specific nuances.
Consultants’ expertise in this field reduces the likelihood of errors, avoiding the risk of delayed approval or even outright rejections. Their comprehensive understanding of both product development and regulatory strategy helps ensure that drug products adhere to the stringent requirements commonplace in this field.
2. Operational efficiency and cost-effectiveness
Hiring and training an in-house submission preparation team can be time-consuming and expensive, but outsourcing removes these burdens, allowing organizations to focus more on core operations such as clinical development and R&D.
Consultants leverage regulatory intelligence platforms and other advanced tools to streamline the submission process, improving its efficiency. For example, the use of industry-leading regulatory intelligence platforms can lower the time required to create a submission by as much as 50 %.
Consultants who can harmonize multidisciplinary inputs can offer significant benefits to a pharmaceutical company preparing an NDA or Biologics License Application (BLA).
These inputs range from clinical trial data to manufacturing reports, and a consultant able to leverage these inputs to create well-structured, compliant documents will significantly expedite regulatory review cycles.
Their services also ensure consistent and precise submissions that include robust analytical method validations and comprehensive development plans.
3. Global market navigation
Expansion into international markets involves a number of challenges beyond the most obvious issue of language translation. For example, agencies in Tokyo, Singapore, and other regions regularly adopt different interpretations of ICH (International Council for Harmonisation) guidelines.
Regulatory consultants offer indispensable localized expertise, ensuring submissions meet the requirements of each individual market.
For example, the FDA may prioritize post-marketing surveillance protocols while the EMA places more emphasis on environmental risk assessments. Consultants will tailor submissions to address these specific nuances, avoiding potentially expensive mistakes and ensuring that the manufacturing process meets regional regulatory authorities’ expectations.
4. Improved risk management
Regulatory pathways feature an array of potential challenges—from unforeseen compliance issues to constantly shifting guidelines. Consultants will work to proactively identify these challenges and their associated risks, offering mitigation strategies grounded in scientific rationale and precedent.
For example, a company may face scrutiny over missing quality attribute tests in its CMC section. In this instance, consultants could propose scientifically valid alternatives, drawing on historical approvals to justify their approach.
This foresight could potentially streamline the approval process, preventing time-consuming back-and-forth with regulators.
5. Enhanced submission quality
High-quality submission content involves more than just meeting basic compliance requirements—data must be presented in a way that facilitates regulatory decision-making. Regulatory consultants boast considerable expertise in structuring submissions that are compelling as well as complete.
6. Access to thought leadership
Industry-leading consultants are typically at the forefront of regulatory trends, presenting at key events like the Annual DIA Global Meeting. This provides their clients with a considerable competitive edge, allowing them to benefit from the latest compliance technologies and methodologies, for example, AI-driven regulatory intelligence.
AI tools are seeing increasingly widespread use to optimize dossier content and predict regulator queries. These tools can identify common patterns in queries, allowing issues to be addressed pre-emptively and helping to optimize dossier content for closer alignment with regulatory expectations.
Working with consultants who are working with these innovations can considerably improve submission outcomes while also streamlining post-approval requirements.
7. Strategic partnership for long-term success
Outsourcing is more than a transactional relationship; rather, it is a strategic partnership. Consultants support companies in developing internal capabilities via training and knowledge transfer, empowering teams to better navigate future submissions.
It is also important to note that because environmental sustainability is now a central regulatory priority, good consultants can help companies align with emerging green compliance standards, securing approvals while ensuring appropriate corporate responsibility.
Consultants’ involvement in regulatory strategy and the manufacturing process fosters long-term success in terms of meeting regulatory authorities’ expectations.
Empowering the regulatory journey
It is strategically imperative to outsource submission content development to regulatory affairs consultants in the current pharmaceutical landscape.
DS InPharmatics (DSI) offers a comprehensive range of services designed to support drug development from initial investigational submissions (IMPD, IND, CTA) through to final marketing applications (MAA, NDA, NDS).
The company’s team excels in the hands-on and strategic aspects of the regulatory process, including submission content development and project management.
Working with DSI ensures that submissions are meticulously prepared and compliant with agency requirements. Powerful tools like Microsoft Project and Smart Sheets are used to coordinate and track critical path topics.
Partnering with DSI allows manufacturers to gain access to a wealth of knowledge and experience, allowing them to efficiently navigate the complexities of regulatory submissions.
DSI’s integrated approach streamlines the submission process while simultaneously enhancing application quality, increasing the likelihood of favorable regulatory agency reviews.
As a dependable partner for an industry where precision and compliance are paramount, DSI’s team is committed to delivering excellence in regulatory affairs services.
Acknowledgments
Produced from materials originally authored by Meranda Parascandola from DSInpharmatics.
About Design Space InPharmatics LLC
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.