Developing and delivering a pharmaceutical product to patients involves more than clinical success—it requires a well-planned and expertly executed regulatory strategy. At Omnee Strategic Solutions, we provide comprehensive regulatory affairs support tailored to the unique challenges of pharmaceutical development, registration, and post-market maintenance.
From early clinical planning to global submissions and inspection readiness, our team offers deep regulatory expertise and a hands-on approach to help you accelerate timelines, minimize risk, and achieve compliance across all major markets.
Whether you’re preparing an IND, navigating an NDA or MAA, or managing post-approval changes, we act as an extension of your team—ensuring your product meets regulatory expectations and reaches patients efficiently and compliantly.
Global Regulatory Submissions
Drive successful submissions through strategic planning, content development, and regulatory coordination.
IND / CTA Preparation and Maintenance
We provide comprehensive support for Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions, ensuring that your early-phase development programs start on the right path. Our team assists with authoring, reviewing, and assembling key modules—including preclinical, clinical, and CMC sections—while ensuring alignment with FDA, EMA, and other global authority expectations. Post-submission, we manage ongoing maintenance activities such as safety reports, protocol amendments, and correspondence to keep your trial compliant and uninterrupted.
NDA, BLA, and MAA Strategy and Execution
Navigating the path to market authorization requires a precise regulatory strategy and rigorous execution. We support New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA) by developing submission roadmaps, coordinating with cross-functional teams, and ensuring your data is clearly and compliantly presented. From gap assessments to responding to health authority questions, we help you reduce risk, avoid delays, and move confidently toward approval.
eCTD Compilation and Submission Oversight
Our team ensures your submissions meet electronic Common Technical Document (eCTD) standards, providing end-to-end management of formatting, structure, publishing, and validation. We coordinate with publishers and internal teams to ensure technical accuracy, document consistency, and submission readiness. Whether it’s an original submission or a post-approval update, we help you avoid technical rejections and streamline your interactions with global regulatory agencies.
Lifecycle Management (Amendments, Variations, Annual Reports)
Regulatory responsibilities don’t end with approval—ongoing compliance is essential to maintain your product’s market presence. We manage all aspects of lifecycle submissions, including CMC and labeling updates, safety-related changes, and administrative variations. From preparing annual reports and PSURs to implementing global variations across multiple regions, we help you stay current with regulatory requirements and ensure uninterrupted product availability.
Regulatory Strategy & Development Support
Achieving regulatory success begins long before a submission is filed. We provide strategic guidance from the earliest stages of development to help you make smarter decisions, reduce uncertainty, and avoid costly delays. Our regulatory strategy and development support services are designed to align your clinical, CMC, and regulatory efforts with global requirements—giving you a clear path forward at every phase of the product lifecycle.
We help you identify the optimal regulatory pathway for your product based on its classification, indication, and market goals. Through gap assessments, regulatory precedent research, and early interaction planning, we provide clarity on the most efficient route to approval and the data needed to support it.
Innovative products require tailored strategies that consider both scientific complexity and evolving regulatory expectations. We work with your team to develop integrated global plans that support efficient development, enable simultaneous filings across multiple regions, and accommodate accelerated pathways when applicable.
We provide end-to-end support for critical meetings with regulatory authorities, including meeting request preparation, briefing document development, and rehearsal sessions. Whether you’re engaging with the FDA, EMA, or other agencies, we ensure your team is prepared, aligned, and positioned to gain clear, actionable feedback.
We proactively assess potential regulatory risks in your development program—whether scientific, procedural, or logistical—and develop mitigation strategies to address them. Our approach ensures that your team can make informed decisions early, avoid common pitfalls, and maintain momentum toward approval.
Compliance & Regulatory Standards
Maintaining compliance in an ever-evolving global regulatory environment requires proactive planning and ongoing alignment with international standards. We support pharmaceutical and medical device companies by conducting regulatory intelligence and gap assessments, ensuring adherence to ICH, FDA, EMA, and other regional requirements. Our team also assists with the implementation of complex data standards such as Structured Product Labeling (SPL), IDMP, and XEVMPD, while reviewing SOPs and regulatory documentation to strengthen audit readiness and ensure long-term compliance.
Audit & Inspection Readiness
Be confident and prepared for regulatory inspections and sponsor audits with our comprehensive audit readiness support. We assist with detailed regulatory document audits—including IND, NDA, and CTA modules—while providing customized inspection readiness training and mock audits. Our team helps you identify gaps, develop effective CAPA and remediation plans, and ensure cross-functional alignment to meet FDA, EMA, and other global regulatory expectations. With our proactive approach, you’ll be inspection-ready and positioned for compliance success.