Dossier Development and Audits

Dossier Audits:

Comprehensive Evaluation:

• Our experienced regulatory experts conduct thorough audits of your existing regulatory dossiers to identify strengths, weaknesses, and areas for improvement.
• We evaluate the accuracy, completeness, and compliance of the documentation with current legislation and regulatory guidelines.

Gap Analysis:

• ERA performs gap analyses to pinpoint any missing or incomplete data and documentation within your dossiers.
• We provide clear recommendations for addressing any gaps and enhancing dossier quality in the form of a report.

Regulatory Compliance:

• Our team ensures that your dossiers align with the latest regulatory requirements and guidelines, whether for initial submissions, variations, or renewals.
• We work proactively to address potential compliance issues before they become regulatory challenges.

Dossier Development:

Customized Development Strategies:

• We collaborate with you to create tailored strategies for dossier development based on your product’s unique characteristics and regulatory goals.
• Our experts guide you through the entire process, from document compilation to submission and beyond.

Document Preparation and Compilation:

• ERA assists in the preparation and compilation of all required documentation for your regulatory submissions.
• We ensure that your dossiers are structured, organized, and presented in a manner that facilitates efficient regulatory review.

Regulatory Submission Support:

• We offer support throughout the entire submission process, including interactions with regulatory authorities (throughout the EU and UK) and addressing any inquiries or requests for additional information you might receive from them.
• ERA ensures that your dossiers meet the reasonable expectations of regulatory agencies for a smoother approval process.

Quality Overall Summaries (QOS):

If you already have a high-quality dossier and you just need some Module 2 support we can do that too.

• Our experienced team prepare Quality Overall Summaries (QOS) that consolidate all Module 3 data into a coherent and compliant document for regulatory submission.
• We ensure that QOS documents are precise and comprehensive.

By leveraging our clinical, non-clinical and quality expertise, you can be confident in the quality and regulatory compliance of your MAs and MAAs. ERA is dedicated to optimizing your product’s path to market by providing strategic insights, meticulous documentation, and expert support throughout the regulatory approval process.

By entrusting ERA with your dossier audits and development, you gain a partner dedicated to enhancing the quality and compliance of your regulatory submissions. Our commitment to rigorous evaluation, strategic planning, and regulatory expertise ensures that your dossiers are well-prepared for successful regulatory outcomes