Global Regulatory Solutions

Strategic Expertise to Navigate Complex Regulatory Pathways

The Global Regulatory Solutions (GRS) team at iGlobal delivers expert strategic guidance and operational excellence to streamline the development and approval of safe and effective medical therapeutics. Spanning the entire product lifecycle—from preclinical proof-of-concept to regulatory submission, postmarketing maintenance, and label extensions—our GRS experts collaborate with you to navigate the complexities of the ever-evolving regulatory landscape. With a focus on achieving long-term commercial success, we partner with you to accelerate timelines, ensure compliance, and bring innovative therapies to market efficiently.

Regulatory Leadership for Accelerated Approvals

Global Insight, Strategic Execution

iGlobal's Global Regulatory Solutions (GRS) team delivers scientifically grounded, therapeutically focused strategies to accelerate product approvals. Whether you're an emerging biotech company or a global pharmaceutical leader, we ensure compliance with international standards while keeping your product development on track.

Key Benefits of Partnering with iGlobal GRS

  • Innovative regulatory strategies to fast-track approvals.
  • Expertise in global, regional, and local regulatory requirements.
  • Support for small- and large-scale programs across drugs, biologics, and medical devices.

Our Comprehensive Services

Preclinical & Clinical Development Strategy

  • Design and implementation of global regulatory strategies aligned with therapeutic goals.
  • Advisory meeting preparation and regulatory submission readiness.
  • Risk assessment and mitigation planning for safety and compliance.

Regulatory Documentation & Submission Management

  • High-quality preparation of clinical trial (IND/CTA) and marketing applications (NDA/BLA/MAA).
  • Dossier management tailored to region-specific requirements.
  • Authoring nonclinical, clinical, and technical sections for seamless regulatory submissions.

Postmarketing & Label Maintenance

  • Lifecycle management, including safety updates and periodic reporting.
  • Strategic planning for label extensions to maximize commercial potential.

Regulatory Operations & Project Management

  • Coordinated regulatory activities to meet critical timelines.
  • Real-time communication and seamless integration of operational tools.

The iGlobal Advantage

  1. Global Reach, Local Expertise: Leverage international networks and regional insights.
  2. Therapeutically Focused Teams: Specialists in oncology, rare diseases, and advanced therapies.
  3. Innovative Problem Solvers: Proactive risk management and streamlined approvals.
  4. Full-Spectrum Support: Comprehensive services from preclinical strategy to postmarketing.
  5. Integrated Solutions: Collaborative teams ensure regulatory, safety, and operational alignment.

Medical Writing Services

Expertly Crafted Documentation for Every Stage

iGlobal’s Medical Writing team produces clear, scientifically accurate documentation that supports clinical trials and accelerates regulatory approvals. With advanced degrees and therapeutic expertise, our writers deliver regulatory-aligned, high-quality documents.

Comprehensive Medical Writing Solutions

  • Protocols & Amendments: Detailed and adaptable protocols for evolving studies.
  • Clinical Study Reports (CSRs): Comprehensive trial results for regulatory submission.
  • Investigational & Marketing Applications: INDs, IMPDs, and MAAs tailored for compliance.
  • Summary Documents: Concise safety and efficacy summaries for efficient reviews.

Why Choose iGlobal Medical Writing?

  1. Therapeutic Expertise: Skilled across oncology, neurology, infectious diseases, and rare conditions.
  2. Regulatory Precision: Documents aligned with global regulatory standards.
  3. Collaborative Approach: Tailored solutions developed with sponsors to meet unique goals.
  4. Quality Assurance: Rigorous quality control for clarity and compliance.

Integrated within iGlobal’s End-to-End Regulatory Support Services, our Medical Writing team works closely with Regulatory, Clinical, and Operational experts to ensure documentation aligns with your strategy, timelines, and regulatory objectives.

Choose iGlobal Clinical Research for medical writing services that deliver clarity, precision, and compliance—empowering your trial with the documentation needed for success.