End-to-End Regulatory Services: Compliance and Speed to market

At Navitas Life Sciences, we are at the forefront of providing comprehensive regulatory services that ensure compliance, accelerate time-to-market, and enhance patient outcomes. Our commitment to innovation, precision, and excellence helps us shape personalised solutions to support across the entire product lifecycle. Navitas Life Sciences understands these challenges and offers robust regulatory compliance services that address regulatory requirements efficiently and effectively.

Comprehensive Regulatory Services

Our end-to-end regulatory services are designed to support life sciences, pharma and biotech companies at every stage of the product lifecycle. From initial development to post-market surveillance, we provide expert guidance and support to ensure regulatory compliance and expedite product approval.

Regulatory Strategy and Planning

As a part of regulatory affairs services, a well-defined regulatory strategy is crucial for successful product development and commercialization. Our team of experts collaborates with clients to develop tailored regulatory strategies that align with their business objectives. We conduct thorough regulatory assessments, identify potential risks, and devise mitigation plans to streamline the approval process.

Regulatory Submissions and Approvals

Navitas Life Sciences’ regulatory and compliance services simplify submission process by managing all aspects of regulatory submissions, including preparation, compilation, and submission of dossiers. Our expertise in electronic Common Technical Document (eCTD) submissions ensures that documents are formatted correctly and meet regulatory requirements, reducing the risk of delays and rejections.

Regulatory Intelligence and Compliance

Staying informed about the latest regulatory changes is essential for maintaining compliance. Our regulatory intelligence services provide real-time updates on regulatory developments, helping clients adapt to new requirements and maintain compliance. We also offer comprehensive pharmaceutical regulatory consulting services, including audits, gap analyses, and remediation plans, to ensure that companies meet all regulatory obligations.

Expertise in Global Regulatory Affairs

In today’s globalized market, life sciences companies must cater to regulatory requirements across multiple regions. Navitas Life Sciences has a deep understanding of global regulatory affairs and provides localized support to ensure compliance with regional regulations.

North America

The regulatory environment in North America, particularly in the United States, is highly stringent. We assist clients in meeting the requirements of the U.S. Food and Drug Administration (FDA) and Health Canada, providing support for Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and more.

Europe

Europe’s regulatory landscape is complex, with multiple regulatory bodies and guidelines. Our experts are well-versed in the European Medicines Agency (EMA) requirements and assist clients in obtaining approvals for Clinical Trial Applications (CTA), Marketing Authorization Applications (MAA), and other regulatory submissions.

Asia-Pacific

The Asia-Pacific region presents unique regulatory challenges and opportunities. We offer comprehensive support for navigating the regulatory environments in countries such as China, Japan, India, and Australia, helping clients achieve compliance and expedite market entry.

End-to-End Regulatory Services

Ravi Sharma, Manager of Regulatory Operations, has shared in-depth perspectives on how our end-to-end solutions ensure compliance, accelerate time-to-market, and enhance patient outcomes. In our latest blog, we sat down with Mr. Ravi Sharma to explore some parts of the interview to understand the comprehensive regulatory services offered by Navitas Life Sciences.

Ravi Sharma

Manager of Regulatory Operations,

Navitas Life Sciences

Please provide a brief overview of the end-to-end regulatory services offered by Navitas Life Sciences?

Navitas Life Sciences offers a comprehensive suite of end-to-end regulatory services designed to support life sciences companies at every stage of the product lifecycle. Our offerings include regulatory strategy support, regulatory consulting, CMC authoring and gap analysis, publishing and submissions, regulatory labeling and artwork, regulatory medical writing, safety and pharmacovigilance, health authority interactions, local agent and establishment support, translation services, lifecycle management, audit and validation, local on-the-ground presence, and support to supply chain and commercialization.

How do our regulatory services differ from those offered by other companies in the industry?

Navitas Life Sciences’ regulatory compliance consulting services stands out in the industry with its unique approach. We leverage technology-enabled services to streamline processes and ensure accuracy. Our 24/7 support across geographies ensures that our clients receive continuous assistance regardless of their location. We boast a diversified expertise through our regulatory domain experts, ensuring that our clients benefit from a wealth of knowledge and experience. Our commitment to right-first-time submissions and a quality-centric approach further distinguishes us from other service providers. Additionally, we offer local agent or establishment support to facilitate compliance with regional regulations.

How does Navitas Life Sciences ensure compliance with the diverse regulatory requirements of different global markets?

Navitas Life Sciences ensures regulatory compliance across diverse global markets through a combination of advanced tools and robust strategies. Our in-house application, eQMS, and pharmaREADY^® tool are instrumental in tracking and managing quality compliance activities. Additionally, our in-house regulatory intelligence and well-crafted regulatory strategies for each submission cover all aspects of regulatory filings, ensuring that our clients meet the stringent requirements of different regulatory bodies worldwide.

What advice would you give to companies looking to improve their regulatory strategies and ensure smoother product launches?

To companies looking to enhance their regulatory services and ensure smoother product launches, my advice is twofold. First, selecting the right procedure for submission can lead to faster approvals. Procedures such as the International Recognition Procedure (IRP), reliance pathways, and mutual recognition procedures are among the fastest routes to product approval. Second, embracing technology is vital. Technology-enabled regulatory services enhance compliance and accuracy, making them an optimal choice for companies aiming to streamline their regulatory processes and achieve timely approvals.

Experts Speak: Listen to Ravi Sharma as he speaks about End-to-End Regulatory Services offered by Navitas Life Sciences

Get Insights into the world of Regulatory Consulting services Now

Navitas Life Sciences works closely with industry partners, regulatory bodies, and technology providers to stay ahead of regulatory trends and deliver cutting-edge solutions. Insights from our industry leading networks ensure that we remain at the forefront of regulatory advancements and continue to provide our clients with the best possible services.

Our comprehensive, technology-driven regulatory services enable clients to achieve compliance and accelerate time-to-market. With a commitment to innovation, quality, and excellence, we empower our clients to driver faster market reach and ensure patient safety.

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.