CRO Regulatory Affairs: Bridging Strategy, Compliance, and Speed
Bringing a new therapy to patients is as much a regulatory journey as it is a scientific one. Every submission, meeting, and document must align perfectly with evolving international standards — from FDA INDs and NDAs to EMA CTIS, IMPDs, and the EU CTR framework.
At Cromos Pharma, we view regulatory affairs not as an administrative necessity but as a strategic driver that helps sponsors move from preclinical proof-of-concept to market authorization efficiently and compliantly. Our regulatory experts combine global insight with operational agility to help sponsors navigate multi-jurisdictional submissions, manage timelines, and achieve faster approvals.
Two Frameworks, One Language of Quality
Behind every strong regulatory strategy lies a strong quality foundation. Cromos Pharma integrates two global standards — — ensuring consistent quality management, documentation integrity, and inspection readiness across all submissions. For a deeper look at how these frameworks work together, explore our article ISO 9001:2015 and ICH GCP E6 (R3): Two Standards, One Language of Quality in Clinical Research.
CRO Regulatory Affairs: Navigating the Global Regulatory Landscape
The complexity of drug development grows with every country added to a trial. Each region brings unique expectations, submission pathways, and documentation formats. Cromos Pharma’s global regulatory affairs team provides harmonized strategies tailored to each authority’s requirements.
United States
Our regulatory specialists guide sponsors through FDA-regulated pathways such as IND, IDE, and NDA/BLA — including hybrid and 505(b)(2) programs.
Regulatory Support Area | Description |
FDA Meetings | Pre-IND, End-of-Phase, and Type B/C meetings — including preparation of meeting requests, briefing packages, and Q&A tracking. |
Briefing Book Preparation | Development, formatting, and logistics for briefing packages — ensuring clarity, traceability, and reviewer alignment. |
Lifecycle Management | Post-marketing commitments, variations, and regulatory maintenance to ensure long-term compliance |
European Union
Under the EU CTR (EU 536/2014), Cromos Pharma helps sponsors navigate the Clinical Trials Information System (CTIS) — ensuring correct dossier architecture, smooth validation, and timely RFI responses. Our regulatory team compiles and submits CTAs and also manages related lifecycle activities — including SMs, Notifications (e.g. trial start, end, or temporary halt), Addition of Member States Concerned, ASRs, Trial Results Posting in CTIS. ,and MAA support services. We also manage PIP and ODD submissions in IRIS, and interacts with the EMA, and national authorities.
Since the regulation became fully applicable in 2023, many sponsors continue to face challenges with Part I/Part II division, submission workflows, and harmonization across Member States. Cromos Pharma has successfully guided multiple clients through these transitions — assembling compliant dossiers, managing RFIs, and avoiding costly clock-stops.
For practical guidance, watch our Mastering CTIS Webinar, where Cromos Pharma experts share best practices, real-world case studies, and strategies to streamline the CTIS submission lifecycle.
To understand how regulatory expectations differ globally, read our insight “FDA vs. EMA: Navigating Divergent Regulatory Expectations for Cell and Gene Therapies”, which explores evidence standards, data transparency, and global harmonization.
Emerging Europe and Beyond
Cromos Pharma delivers regional regulatory expertise not only in the US and the EU, but also beyond these regions — in countries such as Turkey, Israel, Kazakhstan, Georgia, Ukraine, and Serbia. This global footprint enables sponsors to access diverse and fast-growing clinical trial markets while maintaining full compliance with EU and ICH GCP standards. Our experience supports accelerated patient enrollment and streamlined regulatory submissions under unified oversight.
From Briefing Books to eCTD: The Power of Precision
Behind every successful submission is a well-structured documentation package.
Our regulatory writers prepare:
- Protocols, Synopses, Clinical Study Reports
- Risk-Management Plans and Summary Documents
- Technical and Quality Modules formatted for eCTD compilation and lifecycle management
Each document undergoes rigorous scientific and quality review to ensure alignment with GCP standards and regional expectations.
Our publishing team implements eCTD 4.0-ready templates and metadata to maintain data integrity and traceability throughout the regulatory lifecycle.
Expedited Pathways and Special Designations
Speed is critical — especially in oncology, rare diseases, and advanced therapies. Cromos Pharma’s regulatory affairs team identifies and secures acceleration opportunities across both FDA and EMA frameworks.
Agency | Program | Purpose |
FDA (U.S.) | Fast Track, Breakthrough Therapy, Priority Review, Orphan Drug | Accelerate development and shorten FDA review timelines |
EMA (EU) | Enable earlier dialogue and faster evaluation for high-impact therapies | |
Cross-Agency | Ensure regulatory and ethical alignment for pediatric and rare disease populations |
By integrating regulatory strategy and evidence generation early, Cromos Pharma helps sponsors reduce timelines, strengthen submissions, and maximize the probability of first-cycle approval.
Global Integration: Consistency Across Submissions
In multi-country trials, our teams support the harmonization across CMC modules, and ensure consistency labeling, and trial documentation, maintaining consistency between eCTD, NeeS, and CTIS submissions — so your regulatory story remains coherent wherever it’s reviewed.
Partnering with Cromos Pharma
In a constantly shifting regulatory environment, proactive guidance is the key to success. Cromos Pharma combines scientific rigor with operational flexibility to help sponsors meet — and exceed — global regulatory expectations.
Whether planning your first IND, transitioning to EU CTR / CTIS, or pursuing expedited designations, our regulatory affairs CRO team is ready to support your next submission strategy.
Leave a request for a free consultation, and our experts will get in touch to discuss your project and outline the most efficient regulatory pathway.
