Global Regulatory Submissions and Outsourcing

Accelerate and streamline your global regulatory submissions

More than 40 years ago, Parexel started as a regulatory consulting firm. Now with a global footprint and team of 1000+ regulatory professionals, including 80+ former regulators, we navigate complex and evolving global regulations.

Optimize your in-house teams and focus on strategic initiatives to achieve your corporate goals. Our services in support include: 

• Submission strategy: Develop an effective regulatory submission plan with tailored guidance and support
• Technical authoring: Craft accurate and compliant regulatory documents with expert assistance
• Regulatory dossier preparation, publishing and submission: Efficient and first-time quality delivery of regulatory dossiers through streamlined processes
• Support throughout dossier review until approval: Address any concerns and provide timely responses to the global regulatory authorities with continuous guidance and expertise
• Global market support: Navigate regulatory requirements and expand your products’ reach in international markets
• Post-approval submissions and lifecycle maintenance: Ensure compliance and regulatory adherence throughout the product’s lifecycle with comprehensive global support
• Regulatory information management: For data entry, cleansing and maintenance
• Staff augmentation: Supplement your team with experienced regulatory professionals when needed, globally

Therapeutic alignment

Navigating the regulatory landscape in drug development is more than just knowing the regulations. It also requires a deep understanding of the specific challenges associated with different indications and therapeutic areas. Our team goes beyond traditional regulatory consulting to offer invaluable insights into the intricacies of various therapeutic areas, combining medical, clinical, and regulatory expertise. This holistic approach is crucial to achieving success in the complex world of drug development.

Your Parexel single point-of-contact for ease of business

To deliver seamless and efficient services, we offer a single dedicated point of contact to oversee your program of work. Working to maintain efficient communication and streamlined processes, we align our experts with your time zone, enabling real-time engagement and rapid response. With our comprehensive expertise and client-centric approach, we are fully committed to delivering exceptional results throughout our engagement.

Global regulatory submissions and outsourcing

Submission strategy

In close client partnership, we develop marketing application submission strategy, considering regulatory requirements, regional differences, and market access requirements. Our goal is to optimize the submission process and increase the chances of successful approvals.

Technical authoring

Develop accurate and compliant documents including common technical documents (CTD), summary of product characteristic (SmPC), labelling and patient information leaflets (PILs) with our team. We compile, analyze data, craft clear narratives, ensure regulatory compliance and provide localization and translation support. By leveraging our expertise in technical authoring, companies can enhance their documentation quality, streamline the regulatory review process and increase the likelihood of successful market authorization in global markets.

Regulatory dossier compilation, publishing, and dispatch

Efficiently prepare the required documentation, ensuring compliance with regulatory guidelines. Our team handles the technical aspects, including data analysis, narrative development, and quality assurance. Additionally, we provide publishing services preparing the submission in the appropriate format for electronic submission.

Global market support

Tailor your market application strategies to specific countries or regions, with our deep understanding of regional regulatory requirements. We leverage the local insights of our truly global team to consider regional guidelines, cultural nuances and language requirements to optimize submissions and improve the chances of successful approvals.

Post-approval submissions and lifecycle maintenance

Through comprehensive support in areas like labeling updates and variations, we allow companies to free up their internal teams to focus on strategic activities while ensuring compliance.

Regulatory information management

Get your products to market faster and maintain them efficiently and cost-effectively with our end-to-end platform for submission planning, publishing, viewing, and registration management.

Staff augmentation

Companies often face peaks and troughs in their workload, and we provide tailored solutions to address these fluctuations. Our team can seamlessly integrate with our clients’ internal teams, providing expertise and resources to augment their regulatory capabilities.

A trusted partner

With a team of 1000+ regulatory professionals, including 80+ former regulators, Parexel has the knowledge, insights and technology-enabled processes to accelerate and streamline your drug development journey. With experience in more than 110 countries, we provide strategic regulatory advice, proactively identify and mitigate risks and navigate the ever-evolving regulatory landscape. Our deep therapeutic insight and proven track record make us a reliable partner for achieving regulatory success.