Regulatory Strategy & Submissions
Global Regulatory Strategy & Submissions Consulting for MAHs and Sponsors
GPLACO SOLUTIONS delivers Regulatory strategy and submission consulting for global Pharma and biotech sponsors seeking FDA IND submission consulting, NDA regulatory consulting services, and EMA MAA consulting services. We support organizations with IND submission support for biotech, EU CTA submission support, and FDA-compliant eCTD publishing, helping clients avoid FDA clinical holds, prevent Refuse-to-File (RTF) deficiencies, and achieve inspection-ready submissions aligned with FDA, EMA, MHRA, PMDA, TGDA, and ICH expectations. Our regulatory strategies are built for executives who need speed, predictability, and regulatory confidence across the full product lifecycle.
A Proactive Regulatory Strategy for Global Compliance.
Comprehensive Submission & Lifecycle Management
We provide end-to-end Regulatory strategy and submission consulting from early clinical development through post-marketing lifecycle management. Our teams synchronize clinical data, safety strategy, and regulatory milestones to deliver globally aligned submissions that withstand regulatory scrutiny across FDA, EMA, MHRA, PMDA, and other key agencies.
US FDA Filing Support (IND/NDA)
Strategic management of Investigational New Drug (IND) and New Drug Applications (NDA), including gap assessments, module strategy, and submission readiness. We structure safety and technical data to meet FDA expectations and proactively mitigate clinical hold and RTF risks.
EU Submissions (CTA/MAA)
Expert regulatory consulting and filing for EU Clinical Trial Applications (CTA) and Marketing Authorization Applications (MAA). We guide sponsors through EMA centralized, decentralized, and national procedures, ensuring regulatory positioning that accelerates EU market access.
Protocol & IB Development
Clinical Development Documents - Scientific authoring and regulatory review of Clinical Trial Protocols and Investigator’s Brochures (IB). We ensure your documents are built for regulatory acceptance, prioritize subject safety and inspection readiness across FDA and EMA reviews.
Core & Safety Labeling strategy
Global labeling and maintenance of the CCDS, CCSI, SmPC, RSI and USPI. We ensure consistency across global markets while managing the internal product safety information for MAHs and Sponsors that support benefit-risk clarity and regulatory consistency..
eCTD Publishing & Electronic Submissions
Lifecycle management of electronic Common Technical Document (eCTD) submissions. We ensure dossiers are formatted, validated, and submitted in compliance with the latest FDA and EMA technical specifications, reducing submission rework and authority queries.
Global Regulatory Intelligence & Submission Standards
AI-enabled monitoring of regulatory guidelines, authority updates, and submission standards. This enables real-time regulatory intelligence to ensure submissions remain aligned with evolving FDA, EMA, MHRA, PMDA, TGDA, and ICH requirements.
Aggregate Reporting & Risk Management (DSUR / PSUR / PBRER)
High-quality, on-schedule delivery of DSUR, PSUR/PBRER, and PADER, with strict Data Lock Point (DLP) control and global alignment. Our approach minimizes Health Authority questions and supports RMP/REMS regulatory strategy.
Electronic Submission Standards
AI technologies contribute to ensuring compliance with electronic submission standards, improving the accuracy and completeness of electronic submissions.
Advantages of AI/ML-Enabled Regulatory strategy and submission consulting
Proactive Compliance and Enhanced Efficiency
Stay ahead of evolving global requirements with real-time monitoring and automated alerts for proactive strategy adjustments. By utilizing AI, we ensure your Regulatory Strategy and Submissions remain fully aligned with new FDA and EMA guidance documents and the latest legal standards, preventing costly delays before they even occur.
Automated processes streamline complex documentation workflows, significantly reducing human errors in Regulatory Strategy and Submissions. Machine learning algorithms can now perform automated quality checks on eCTD dossiers, identifying structural inconsistencies or broken hyperlinks in minutes.
Predictive analytics identify potential compliance risks by cross-referencing your current data against historical agency "Refusal to File" patterns. This allow for proactive mitigation during the preparation of your Regulatory Strategy and Submissions, ensuring that safety signals and technical data are presented in a way that minimizes the likelihood of a clinical hold.
Adaptive strategies evolve alongside the dynamic regulatory environment, ensuring long-term asset viability. Our AI-enabled framework allows your Regulatory Strategy and Submissions to pivot rapidly when new safety data or competitor landscape changes emerge, maintaining your market exclusivity and protecting your drug’s lifecycle.
Navigate Regulatory Challenges with Intelligent Solutions
Partner with GPLACO SOLUTIONS for regulatory strategy and submissions consulting designed for executive decision-makers who require speed, predictability, and regulatory certainty across global markets.