Regulatory Assessment and Intelligence

Fervor assess and identify the GAPs and make sure to minimize the possible rejections, addressing delays and accelerate the approval process throughout the product life cycle

Core dossier preparation, compilation and assessment.
End to end API manufacturer guidance.
DCP slot booking & RMS selection
HA liaison and communication Assessment w.r.t. submission/ suspension/withdrawal/ re submission
Regulatory dossier Assessment remediation
Strategy preparation and Product Lifecycle Management
Electronic conversion activity; Paper CEPs into NeeS format
Paper DMFs, INDs and MAAs (non-CTD/CTD) into eCTD format

Regulatory Assessment and GAP analysis

Health Authority Queries Responses

Initial query review and assessment
Regulatory response strategy preparation
HA queries response preparation & submission
Assessment of post-approval submission (CBE-30, Type IB and Type II variations, prior ap-approval supplement, extension applications)
Correspondence with the Regulatory Agencies
Pre-submission communications & Requesting scientific advice from HAs

Optimal Regulatory submission pathway selection.
Mitigation plan development
Gap analysis of developmental data/ source data against current EU Regulatory requirements
Compilation, technical review and submission of IMPDs
Advice for appointment/consultation of QP to address GMP related issues
Regulatory agencies follow up
Response strategy, preparation and on-time submission to HA queries
IMPDs updates /amendments compilation and submission

Investigational Medicinal Product Dossiers (IMPDs)

Regulatory
Intelligence

Less complexity. More clarity

One-stop cost effective Regulatory Intelligence provides world-class content and advanced technology reducing the challenges within the regulatory compliance environment.

Unsurpassed breadth, depth, and quality

Over 100 regulatory bodies and more than 2,500 collections of regulatory and legislative materials, driven by focused analysis, and practical guidance from our global team.

Concise information for a focused view

Focused and concise content within our expertise ensures crystal clarity as per your goals. This simplifies the research process saving your precious time.

Expert, Trusted knowledge

Expertise and knowledge of our team keep you abreast with latest regulatory developments and understand the actual impact of these developments.

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