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Regulatory & Quality Assurance Services
Regulatory & Quality Assurance Services by Creatus Lifesciences
In the life sciences sector, navigating the regulatory landscape and maintaining impeccable quality standards are no longer optional—they are mission-critical. At Creatus Lifesciences, we serve as a strategic partner to pharmaceutical, biotech, and specialty chemical companies, helping them achieve full regulatory alignment, ensure inspection readiness, and build enduring quality systems that withstand global scrutiny.
Our services are built on a foundation of cross-functional expertise, real-world regulatory experience, and a sharp understanding of evolving global standards. Whether you're launching a new molecule, filing in a regulated market, or improving compliance across your manufacturing network—we deliver precise, proactive, and practical solutions
Regulatory Affairs
We offer comprehensive regulatory services that span the entire product lifecycle—from development to post-market maintenance. Our regulatory team works seamlessly with your R&D, RA, and manufacturing functions to ensure that filings are complete, accurate, and regulator-ready.
Global Dossier Development & Submission
We prepare, compile, and submit CTD/eCTD dossiers tailored to the requirements of target markets, covering APIs, finished formulations, intermediates, biologics, and specialty chemicals. Our experience spans filings with USFDA, EMA, CDSCO, PMDA, ANVISA, TGA, and other authorities
Regulatory Intelligence & Roadmapping
Our team provides real-time updates and strategic guidance on regulatory trends, upcoming changes, and optimal registration pathways. We help de-risk submissions and identify fast-track opportunities when available.
Lifecycle Management & Change Control
From post-approval variations and renewals to label updates and periodic safety reporting, we ensure ongoing compliance for your registered products and prevent market disruptions.
Labeling & Promotional Compliance
We help align product artwork, claims, and promotional content with regional regulations to avoid warnings, delays, or rejections.
Quality Assurance
At Creatus Lifesciences, we understand that quality is not just about passing audits—it’s about building sustainable systems that support growth and protect your license to operate.
GxP Audits & Readiness Assessments
Our experts conduct pre-inspection readiness audits, simulate regulator behavior, and support CAPA closure. We help companies prepare for inspections by USFDA, MHRA, WHO, CDSCO, and more.
QMS Design, Review & Optimization
We build Quality Management Systems that are scalable, audit-ready, and built on ICH Q10, WHO TRS, and ISO frameworks. We assist in SOP development, deviation tracking, complaint handling, risk management, and training.
Vendor Qualification & GMP Compliance Audits
We audit and qualify your supply chain partners—CMOs, CROs, raw material vendors, and packaging suppliers—ensuring every partner upholds your quality expectations
Data Integrity & Compliance Systems
We review, validate, and upgrade data management practices for compliance with 21 CFR Part 11, ALCOA+ principles, and other global data integrity norms.
Why Creatus Lifesciences?