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Together, our Regulatory Affairs capabilities form a unified, end-to-end framework that guides your product from concept to market and supports it throughout its lifecycle. We integrate strategy, execution, intelligence, and communication oversight into a single regulatory ecosystem-one that anticipates risks, accelerates development, and ensures global compliance.
Comprehensive regulatory planning grounded in global requirements and product-specific risk.
We help you build the regulatory foundation that accelerates development and minimizes approval risk.
Market-entry pathway determination across U.S., EU, and global authorities
Evidence-driven product classification and jurisdiction mapping to define the right development route
End-to-end regulatory development plans aligned to clinical, CMC, and commercial milestones—connecting scientific, operational, and compliance activities to approval goals
Turning regulatory complexity into actionable strategy—because a smarter path to market starts with the right strategy.
End-to-end support for planning, authoring, assembling, and managing global regulatory submissions.
FDA submissions (IND, NDA, ANDA, BLA, 510(k), and PMA)
EU technical documentation and CE-marking readiness.
Global registration support for ex-US markets
CTD/eCTD strategy, authoring, and submission readiness
Post-submission lifecycle support, including CRL response management, deficiency remediation, and submission amendments
Clear, compliant, and well-structured dossiers that withstand regulatory scrutiny—delivered with precision at every stage.
Ensuring your product claims, labeling, and promotional materials meet global regulatory and privacy standards while supporting clear, credible, and compliant communication.
FDA-compliant labeling development, review, and lifecycle management
Promotional, advertising, and social media content review aligned with FDA/OPDP, FTC, EMA, and MHRA expectations across Rx, OTC, and dietary supplement categories
Claims substantiation, risk assessment, and cross-market regulatory alignment
Digital content governance, including GDPR-aligned practices for websites, campaigns, and social media platforms
Messaging and content oversight to maintain consistency across clinical, marketing, commercial, and digital teams
Global labeling harmonization support, including country-specific considerations and translation-quality workflows
Balanced, defensible, and compliant communication—built to withstand regulatory scrutiny, support market success, and protect user trust.
End-to-end Chemistry, Manufacturing & Controls (CMC) guidance that connects development, quality, and regulatory requirements to accelerate approvals and ensure lifecycle compliance.
Module 3/CMC dossier authoring and gap assessment, including quality narrative development, process descriptions, control strategies, and stability programs
Regulatory impact assessments for change control, translating process, analytical, or supplier changes into actionable global submission plans
Quality and manufacturing readiness reviews, ensuring CMC documentation aligns with facility/equipment capabilities, validation status, and tech transfer milestones
Global lifecycle management, including variations, amendments, annual reports, and post-approval CMC commitments
Cross-functional alignment, integrating CMC, QA, regulatory, and operations inputs to ensure coherent, inspection-ready submissions
Comprehensive CMC support that strengthens regulatory filings, reduces approval risk, and builds a compliant foundation for commercial scale.
From IND-enabling plans to post-approval stewardship, we provide the clarity, structure, and expert navigation needed to advance your program with confidence in every regulatory arena.
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