Regulatory Strategy

Leverage scientific, clinical, and regulatory expertise to de-risk drug development, from the outset

Follow the most efficient regulatory pathway by proactively addressing all facets of drug development. By understanding the intricacies of scientific, clinical and regulatory requirements, you can identify any potential risks earlier, and implement appropriate mitigation strategies.

In the early phases of product development, our global team of ex-regulators and industry specialists provide:

Regulatory intelligence

Regulatory intelligence is a prerequisite to stay informed about the evolving global regulatory landscape. We remain fully up-to-date with the latest changes to FDA and EMA regulations and guidelines, to support our clients to enhance their drug development strategies and navigate the complexities of regulatory requirements, from the early stages of development.

Strategic regulatory advice

With tailored approaches for asset development, from bench to patient, we utilize our teams’ expertise and regulatory intelligence to develop robust regulatory strategies that align with current best practices, including Good Clinical Practice (GCP). Our goal is to enable clients to make informed decisions, navigate the evolving regulatory environment and achieve successful drug development outcomes.

Regulatory authority/agency consulting and engagement

We understand the critical importance of creating a positive first impression with regulatory authorities, with early and frequent engagement. By formulating an optimal approach to engage with authorities, our team of ex-regulators can navigate their expectations and requirements.

Regulatory gap assessment

With comprehensive regulatory gap assessment services, our team evaluates clinical, non-clinical and CMC data, comparing it with national and international regulatory requirements and guidelines. We proactively engage with authorities to check the suitability of existing data, proposed clinical studies and forthcoming marketing approvals with the aim of:

• Identifying any gaps in data
• Defining crucial points for discussions with regulatory authorities
• Establishing a solid foundation for the development plan of your product

Target product profile (TPP) consulting

Define the TPP for your product with guidance on considerations including intended use, patient population, desired efficacy and safety profile, dosage form and route of administration.

Product development plans

With a track record of delivering well-crafted and accurate product development plans, we provide comprehensive support across non-clinical, CMC, and clinical development. Our expertise spans the drug development continuum including study design, regulatory compliance, protocol development, and patient recruitment so we understand the criticality of getting it right. By leveraging our holistic approach, we aim to minimize risk and optimize the potential for success so your product development plan aligns with regulatory requirements and your corporate goals.

A trusted partner

Our dedication to patients and the pursuit of safe and effective drug development is our purpose. With a team of 1,300+ regulatory specialists, including former regulators from agencies across the world, 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.