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Regulatory Strategy
Design global patient-centric regulatory strategies to ensure expedited product development leading to patient access
SOLUTIONS
Product Positioning Strategy
Strategic & accelerated product development
Regulatory submission strategy
Post-approval strategy
Mastering product positioning for market success
By analyzing market trends, competitive products, and regulatory and payer requirements, we help you craft a compelling value proposition that differentiates your product within the market landscape and resonates with all stakeholders.
Optimize your regulatory pathway to market
We provide a comprehensive assessment of the most efficient and compliant roadmap to market. We ensure your regulatory strategy while aligning with the regulatory frameworks applicable to industry, reducing time-to-market, leveraging designations, engaging with patients, and taking advantage of innovative approaches.
Leading and streamlining interactions with regulatory authorities and payers for timely access
Our regulatory and market access experts assist you in preparing for critical meetings with regulatory agencies and payers. We pragmatically ensure you get the most out of these interactions.
Maximizing momentum: Elevating your product’s potential with post-approval strategy
Our post-approval strategy ensures sustained regulatory compliance and optimization of your product’s lifecycle. We provide tailored guidance on post-market surveillance, labeling updates, variations management, and lifecycle maintenance, empowering you to adapt to regulatory changes efficiently and maximize product value throughout its lifespan.
An integrated service
Regulatory strategies covering the full range of activities from early preclinical development to marketing authorization and product lifecycle management, matched with the product’s adequate levels of safety, efficacy, efficiency and quality, as well as manufacturing attributes.
A thorough understanding of global and local-specific regulatory and payers’ requirements
With a strong track record of successful approvals, we excel at anticipating and adapting to regulatory and payer expectations while engaging with patients, driving development forward while minimizing risk.
Our strategic, scientific, technical, and operational expertise spans from product discovery to post-approval, and our long-term, collaborative relationships with clients ensure their unique needs and goals are met effectively.
Building solid foundations for optimized CMC, nonclinical and clinical development
Our team of multidisciplinary experts assists you in designing optimal CMC, nonclinical, and clinical development plans. We create customized study protocols tailored to your product type, ensuring progress and mitigating risks for subsequent steps.
FAQs
Can a regulatory strategy expedite the approval process?
A well-crafted regulatory strategy can help streamline the approval process by ensuring that all necessary requirements are met, submissions are well-prepared, and potential issues are anticipated and addressed proactively.
When should I develop a regulatory strategy for my product?
Regulatory strategy plan is an essential piece part of the Global Product Development Plan.
It should be framed as early as possible and revised during the product development to match the reality of the product and to anticipate any potential hurdles before they arise.
It is key to make informed decisions towards successful placing and maintaining a product on the market. Key components include regulatory pathway analysis, risk assessment, compliance requirements, submission timelines, regulatory agency interactions, and post-approval obligations.
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Related Glossary
Innovative Licensing and Access Pathway (ILAP)
Access Consortium Procedure
INitial Targeted Engagement for Regulatory Advice (INTERACT) meeting
Formal Meetings with FDA
Priority Medicines (PRIME)
Scientific Advice
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.