Preparation and formatting of Common Technical Document (CTD) and electronic CTD (eCTD) dossiers for global regulatory submissions, ensuring accuracy and compliance with international standards.
Strategic guidance and up-to-date regulatory intelligence to optimize submission pathways, accelerate approvals, and maintain compliance in all target markets.
Comprehensive review and gap analysis of existing documentation to ensure submission readiness, identify deficiencies, and support successful approvals.
Ongoing support for variations, renewals, and post-approval changes to maintain product compliance throughout its lifecycle.
Preparation and review of product labeling, packaging, and artwork to meet regulatory and market requirements, reducing approval delays.
End-to-end management of regulatory submissions, including electronic publishing, tracking, and direct liaison with health authorities.
Expert preparation of clinical, nonclinical, and quality summaries, overviews, and responses to authority queries for successful submissions.
Support for product registrations and approvals in emerging and established markets worldwide, ensuring rapid and compliant market entry.