Your Gateway to Regulatory Success and Sustainable Growth.
Welcome to SyncReg Pharma Services, your premier destination for cutting-edge Pharma Regulatory and Quality Services. At SyncReg Pharma Services, we understand that navigating the complex landscape of pharmaceutical regulations is crucial for your success. Our dedicated team of experts is committed to providing unparalleled regulatory consultancy to ensure your products meet compliance standards and reach new heights of success.
With substantial expertise in Chemistry, Manufacturing, and Controls (CMC), our team excels in navigating global regulatory requirements.
From thorough evaluation of Module 3 to authoring and reviewing CMC documentation, we address regulatory issues with scientifically robust solutions. Experienced in both large and small molecules, our consulting services encompass gap analyses, technology transfers, comparability strategies, change control procedures, and Marketing Authorization compliance. At SyncReg, discover unparalleled CMC services tailored to your needs. From formulation development to regulatory support, our client-focused approach ensures quality assurance and efficient project management. Partner with us, whether you're a seasoned industry leader or an innovator, for a seamless journey from concept to commercialization, driving success in pharmaceutical development.
Craft a robust regulatory roadmap tailored to your product portfolio and business objectives.
Developing precise Regulatory Strategies for seamless compliance, ensuring product success through expert analysis, compliance foresight, and strategic planning.
Explore our Regulatory Submission Services, designed to streamline global market entry for pharmaceutical products.
Our seasoned team excels in preparing and filing Registration dossiers, incorporating scientific packages that encompass pertinent data, analysis, and supporting documentation essential for robust regulatory submissions worldwide.
We specialize in diverse submissions such as USDMF, CEP, and ASMF in the eCTD format. Rigorous document review processes are implemented to eliminate queries, while our expertise extends to comprehensive Drug Master File (DMF) compilation and Gap Assessment reviews. Our commitment includes providing authoritative reports on Quality and dedicated assistance in responding to queries, ensuring a smooth journey through regulatory submissions with a focus on precision and success.
Our specialists perform in-depth GAP analysis to evaluate your existing regulatory procedures, pinpointing any data gaps, identifying opportunities for improvement, and enhancing overall compliance measures.
Maximize your product's entire lifecycle with our strategic regulatory guidance.
From initial development through post-market stages, we ensure optimal regulatory compliance and adaptability for sustained success and market relevance.
Explore our audit services, covering GMP/GLP system audits, vendor assessments, gap analyses, internal audits, third-party manufacturing facility inspections, and insightful mock audits. Ensure robust compliance and operational excellence.
Our Quality Management Systems (QMS) are meticulously crafted, ensuring robust frameworks that guarantee adherence to regulatory standards and foster a culture of continuous improvement in pharmaceutical operations.