Streamlined Regulatory Approval & Compliance Services with AI-Powered Solutions

Navitas Life Sciences offers comprehensive regulatory services that empower pharmaceutical, biotechnology, and medical device companies to meet stringent global standards while accelerating time-to-market. By leveraging cutting-edge technologies, such as AI in regulatory compliance and reporting, the company is transforming the way organizations manage regulatory responsibilities.

Comprehensive Regulatory Approval Services

Navitas Life Sciences offers comprehensive regulatory approval services, expertly guiding clients through the complexities of the approval process for IND, NDA, CTA, MAA submissions, and more. With deep industry expertise, we streamline regulatory pathways by leveraging advanced medical writing services and technology driven solutions to create high-quality, compliant documents. From initial submissions to final approvals, we ensure that all regulatory requirements are met, accelerating time to market for our clients’ innovative therapies and products.

Comprehensive Regulatory Compliance Services

Navitas Life Sciences provides a broad spectrum of regulatory compliance services, ensuring that clients maintain adherence to local and Global regulations. Our expertise spans the entire lifecycle of regulatory submissions, from strategy development to post-approval maintenance. Whether providing FDA regulatory consulting services or ensuring global compliance, we tailor our solutions to meet the unique challenges faced. As a trusted partner, Navitas Life Sciences ensures streamlined regulatory pathways, reducing both time and costs for clients.

Growing in Significance: AI-Driven Regulatory Solutions

The integration of AI in regulatory compliance and reporting is a growing aspect in the regulatory space. By deploying advanced AI tools, there is enhanced efficiency of regulatory processes, with automation of routine tasks. This not only reduces the burden on human resources but also increases accuracy and speed in regulatory reporting. As a result, clients benefit from more agile responses to regulatory changes and potential issues.

Generative AI has significantly transformed regulatory submissions and approvals by automating tasks and processes, improving efficiency, accuracy, and compliance. It facilitates content authoring by creating regulatory documents such as clinical study reports and summary reports while generating structured data from clinical trial documents. AI also aids in summarizing complex clinical trial data, converting tables into text, and preparing patient summary reports for each study. Additionally, it automates the conversion of study protocols into informed consent forms (ICF) and enables quick document search and retrieval, streamlining the regulatory submission process.

AI in regulatory reporting is one of the many current topics that will be discussed at RAPS Convergence 2024, where our Senior VP-Business Partner, Regulatory & Safety North, America, Govind Srinivasan, and our Senior Vice President of Regulatory Affairs & Technology, Maalikarjunan R, will be present to discuss the latest trends, insights and how we can support you with your regulatory needs.

In this blog, we will explore some deep insights from our experts about the latest in the regulatory field.

Govind Srinivasan

Senior VP-Business Partner, Regulatory & Safety North, America

What role do you see innovative regulatory strategies like platform trials and real-world evidence playing in streamlining drug development processes?

When evaluating the pursuit of the ACNU (Additional Condition for Nonprescription Use) pathway, it is essential to address both regulatory and nonregulatory considerations. Unlike conventional OTC drugs, ACNUs involve additional development steps and may intersect with other regulatory frameworks, such as device regulations, both within and beyond the FDA’s jurisdiction.

ACNUs may have complex interactions with concurrently marketed prescription products. Our regulatory affairs professionals are skilled in navigating these complexities to achieve successful approval.

At Navitas Life Sciences, we use innovative strategies to assist our sponsors in developing ACNU New Drug Applications (NDAs). Key factors for success include:

• Comprehension Studies : Demonstrate that prospective users understand the information provided in both labeling and any ACNU system.
• Human Factors Studies : Show that prospective users can use the ACNU system effectively and without significant errors.
• Self-Selection Studies : Ensure that users supported by the ACNU system can make informed decisions about its use or the need for professional input without external support.
• Actual Use Studies : Assess how users select and utilize the product in a real-world setting.

How can the FDA’s proposed/new ACNU NDA regulatory pathway be leveraged to improve consumer and patient access to therapies, while also addressing health equity?

The primary goal for sponsors should be to reduce the burden on prospective users by opting for the most accessible solutions available. While digital platforms can offer multiple access points through desktop, mobile, and other electronic systems, improving patient self-directed access to medications and promoting public health, it is crucial to consider the following:

• Minimize Technological Dependence : Explore solutions that are effective yet require less technology, ensuring that the primary goal of improving access is not hindered by the need for advanced tech.
• Accessible Solutions : Focus on creating solutions that are as accessible as possible to all users, regardless of their technological proficiency.

Properly constructed websites and electronic systems can enhance accessibility by offering multiple points of access. However, a balanced approach that considers both technological and low-tech solutions will be most effective in meeting the needs of prospective users and achieving the goal of improved drug access.

From a strategic standpoint, how can companies make the most of model-informed drug development to reduce timelines and costs, while maintaining regulatory compliance?

The key to supporting regulatory compliance, particularly with the FDA, lies in having an appropriate label for use. A well-designed label must convey essential information in a manner that is easily understood by laypersons. This approach not only facilitates smoother FDA approvals but also enhances user reach and satisfaction, which can help sponsors reduce operational costs, accelerate approvals, and save efforts.

To achieve these benefits, labels should be designed with the following considerations:

• Comprehensive Communication : Ensure the label addresses major communication objectives and is designed to facilitate consumer understanding of the product's use.
• Self-Selection : Include elements that assess a consumer's ability to determine if the product is suitable for their needs.
• Device Interaction : For devices, provide clear instructions on how consumers should interact with and use the device effectively.
• Safe and Effective Use : Evaluate whether consumers can use the product safely and effectively in a non-prescription setting.

Maalikarjunan R

Senior Vice President of Regulatory Affairs & Technology

How do you see the integration of the AI Act and MDR requirements evolving, especially in terms of how it impacts technical documentation for medical devices?

The integration of the AI Act with current MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Device Regulation) significantly influences the regulation of AI in digital medical products and AI/ML-enabled devices and systems, ranging from simple software as a medical device to more complex AI-enabled devices.

The AI Act introduces an additional layer of compliance related to GDPR, addressing the handling of personal data both within and outside the EU. This means that AI system providers must adhere to the AI Act when engaging with the European Economic Area (EEA), even if their medical devices are authorized by the US FDA for global regulatory compliance.

For the MDR, IVDR, and AI Act to function cohesively, three critical elements must be addressed:

• Ensuring that AI systems meet rigorous safety and quality standards
• Achieving consistent regulatory requirements and legal clarity
• Supporting the advancement of technology while ensuring compliance

Risk management is a crucial aspect, closely linked with the EU MDR's risk management system. It involves identifying, evaluating, and mitigating the ‘reasonably foreseeable risks’ that high-risk AI systems might pose to health, safety, privacy, and data protection.

Given the multifaceted nature of the AI Act, maintaining comprehensive and compliant technical documentation is essential. This documentation should detail the AI system's elements and development process, including Design specifications, System architecture, Key design choices and their rationale, Data requirements and training methodologies, Computational resources used, Validation and testing procedures, Performance metrics. Such thorough documentation is mandatory to meet global regulatory requirements and ensure the safe and effective deployment of AI technologies

What are some key challenges companies might face when attempting to harmonize AI regulatory frameworks with MDR, and how can we help them navigate these complexities?

One major challenge is understanding best practices for designing and documenting AI-enabled standalone software as medical devices (SaMD). National regulatory bodies have specific jurisdictional requirements, which complicates the development process. For sponsors, key issues include managing cybersecurity and data privacy risks, evaluating safety post-market entry, and handling frequent updates, especially for SaMD products. These issues are not fully addressed by existing regulatory frameworks.

Given the lack of a harmonized standard or regulatory pathway specifically for AI-enabled medical devices (AIaMD), these devices must comply with existing medical device regulations. Additional requirements and approaches are needed to address the unique characteristics of AIaMD.

To navigate these complexities, consider the following approaches:

• Commit to Transparency and Real-World Performance Monitoring: Ensure that AI/ML-based SaMD products adhere to principles of transparency and continuous performance monitoring.
• Open Communication with Regulators: Be upfront and transparent with regulatory bodies regarding the data used in the AI system.
• Data Representativeness, Privacy, and Interpretability: Ensure that the data used is representative, privacy-compliant, and interpretable.
• Establish Communication Procedures: Develop procedures to inform users about updates and changes to the AI system.

By integrating these critical factors during both the development and post-implementation stages, you can better address the regulatory challenges and ensure compliance with existing requirements while managing the unique aspects of AI-enabled devices.

In your view, how can regulatory teams better support the alignment of AI advancements with medical device regulations, ensuring both innovation and compliance?

• Develop a consolidated reference guide that outlines key regulatory requirements, challenges, and considerations. This guide will focus on harmonizing requirements across various regulatory agencies, thereby facilitating realistic compliance with global standards.
• Coordinate with partners to consolidate data collected from various projects, while ensuring anonymity. Building a robust AI training data bank will enhance data representativeness and support sponsoring companies in meeting regulatory expectations.

Navitas Life Sciences’ Specialized Expertise in Medical Devices and Pharmaceuticals

Navitas Life Sciences is a leader in all pharma, including medical device regulatory consulting services. Our team of experts helps manufacturers meet the complex regulatory requirements specific to medical devices, ensuring smooth market entry and continued compliance with evolving standards. In addition to medical devices, the company offers pharmaceutical regulatory consulting services that guide drug development and approval processes. Our deep understanding of both industries enables us to deliver precise regulatory solutions that align with each client’s product portfolio and goals.

Tailored Consulting for Regulatory Challenges

Navitas Life Sciences offers bespoke regulatory compliance consulting services designed to meet the specific needs of pharmaceutical and medical device companies. Our regulatory consulting services cover everything from gap assessments to the development of long-term regulatory strategies.

With specialized expertise in FDA regulatory consulting services, we support our clients with specific requirements of the U.S. market, ensuring that submissions are accurate, complete, and timely. Our global reach allows for seamless support across multiple regulatory environments.

In an industry where regulatory delays can significantly impact product launch timelines, Navitas Life Sciences’ AI-driven solutions and expert consulting services position clients to remain compliant, competitive, and future-ready. By partnering with Navitas Life Sciences, companies can enhance their regulatory processes, allowing them to focus on innovation and growth.