Pharmaceutical Consulting

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Accelerating drug development through expert clinical trial management (Phase I-IV, ICH-GCP), comprehensive regulatory submissions (NDA, ANDA, MAA), technical writing (CMC, CSRs), CMC strategy, pharmacovigilance, and global regulatory support (FDA, EMA, NMPA, TGA, PMDA, Anvisa, etc.).

Navigating the complex landscape of pharmaceutical development and regulatory compliance requires deep expertise and strategic insight. At Regal Intel, we offer comprehensive consulting services designed to streamline your processes, accelerate your timelines, and ensure successful market access. Our team of seasoned consultants brings extensive experience in all phases of pharmaceutical development, from early-stage clinical trials to post-market vigilance, ensuring your products meet the highest global regulatory standards.

Regal Intel's consultants provide expert guidance in the planning, execution, and management of clinical trials, ensuring compliance with ICH-GCP guidelines and relevant regulatory requirements. We assist in protocol development, site selection, data management, and statistical analysis, optimizing trial efficiency and data integrity. Our expertise spans all phases of clinical trials, from Phase I to Phase IV, helping you navigate the complexities of global trials and ensuring timely and accurate data collection for successful regulatory submissions.

Our consultants specialize in the preparation and submission of comprehensive regulatory dossiers, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs). We meticulously compile and review all necessary documentation, ensuring compliance with FDA, EMA, NMPA, TGA, PMDA, Anvisa, and other global regulatory requirements. Our expertise in eCTD submissions streamlines the process, minimizing review times and maximizing the likelihood of successful approvals.

Regal Intel's technical writing team excels in creating clear, concise, and compliant documentation for all stages of pharmaceutical development. We develop comprehensive reports, protocols, SOPs, and regulatory submissions, ensuring adherence to cGMP and ICH guidelines. Our expertise spans various technical documents, including CMC documentation, clinical study reports, and post-market surveillance reports. Our consultants ensure all documentation is accurate, consistent, and readily auditable, facilitating smooth regulatory reviews and approvals.

Our CMC consultants provide expert guidance on the development, manufacturing, and control of pharmaceutical products, ensuring compliance with global regulatory standards. We assist in the development of robust analytical methods, process validation, and stability studies. Our expertise encompasses all aspects of CMC, from API characterization to finished product release, ensuring your products meet stringent quality requirements and regulatory expectations across diverse markets.

Regal Intel's vigilance and monitoring experts ensure the ongoing safety and efficacy of your pharmaceutical products. We develop and implement comprehensive pharmacovigilance systems, ensuring compliance with global reporting requirements. Our services include adverse event reporting, signal detection, risk management, and post-market surveillance. Our proactive approach minimizes risks and ensures continuous compliance, safeguarding patient safety and maintaining regulatory compliance.

Regal Intel provides comprehensive regulatory support across diverse global markets, ensuring your products meet the specific requirements of each region. We are well versed in regulations from the FDA (US), EMA (Europe), NMPA (China), TGA (Australia), PMDA (Japan), Anvisa (Brazil), and many more, We assist in navigating the complexities of regional regulatory landscapes, providing tailored solutions that ensure seamless market access and sustained compliance. Our consultants stay abreast of evolving global regulatory trends, ensuring your strategies remain relevant and effective.