What We Do
Technical/Pharmaceutical Development
Syner-G excels in providing comprehensive development solutions tailored for each stage of your product’s lifecycle. Our team’s expertise covers everything from drug substance and drug product formulation to analytical method development. We are committed to employing Quality by Design (QbD) principles throughout drug development and commercial manufacturing processes to ensure peak efficiency and innovation.
Regulatory Strategy
Navigating the evolving regulatory landscape can be challenging. Our team’s proficiency in navigating the complex regulatory landscape supports the development of robust strategies for new drug applications, including diverse therapeutic entities such as small molecules, biologics, and advanced therapy medicinal products (ATMPs).
Functional Outsourcing
Our Functional Outsourcing Partnership enhances your team’s capabilities through a strategic collaboration. Our dedicated regulatory professionals work closely with your team to boost global program and submission efforts. This synergistic outsourcing model ensures a streamlined and effective regulatory process from the initial stages to final approval, promoting cohesiveness and comprehensive support throughout the drug development lifecycle.
Medical Writing
Our team of expert medical writers plays a pivotal role in the success of your projects by producing high-quality documentation that adheres to regulatory standards at all phases of drug development. This crucial support ensures clear communication and efficient progression through the drug approval processes, facilitating a smoother regulatory journey.
Quality and Compliance
Ensuring regulatory compliance and adherence to cGxP requirements is paramount at Syner-G. These standards are crucial not only for the safety and efficacy of pharmaceutical products but also for successful product development and smooth regulatory approvals. Our approach to quality compliance involves meticulous planning and execution to maintain an uninterrupted supply chain and uphold the highest standards of pharmaceutical quality.
At Syner-G, we understand that each client and project brings unique challenges. Our integrated approach ensures that we provide solutions that are not only compliant with scientific and regulatory standards but also tailored to meet the specific needs of your drug development program. Connect with us to leverage our expertise for your pharmaceutical development success.