One thing that we on the Technical and Quality Assurance (QA) QA team share with every employee throughout Syner-G is intelligence, passion, and unwavering commitment to making a difference. While every department within the organization brings unique knowledge and skill sets to problem-solving, our team is specifically responsible for transforming concepts, ideas, and dreams into tangible products that have the power to transform lives.
We bring a wealth of experience from our previous work in pharmaceuticals or biotechnology. We tap into deep wells of knowledge and expertise to as act scientific leads for clients, for whom we play an indispensable role in ensuring compliance and helping to plan a Chemistry, Manufacturing, and Controls (CMC) strategy. Together, we work in partnership to help develop groundbreaking medicines that address unmet medical needs.
In addition, we play a pivotal role in assisting clients with identifying, creating, and managing manufacturing processes for drug substances and drug products by collaborating with Contract Development and Manufacturing Organizations (CDMOs).
Patient safety is paramount in our work, and we provide an essential layer of checks and balances to ensure compliance with guidelines, regulations, and standards. However, there are challenges to overcome. Clinical trials have become smaller and more adaptive, while budgets have also decreased. As a result, CMC can sometimes become an afterthought. Moreover, the fast-paced nature of the pharmaceutical industry adds to the complexity of our tasks.
Historically, the timeline from concept to approval spanned as long as 10 years. However, some clients now expect that same outcome in as few as three. With this accelerated pace, comprehensive CMC strategies that align with clinical trial requirements and overall client objectives are essential to avoid bottlenecks. We must anticipate potential challenges and have plans in place to navigate them efficiently while maintaining the integrity and duration of the program.
Every project we undertake is unique, requiring us to navigate diverse expectations and constantly acquire and develop new skills. To achieve this, each engagement begins with a series of well-thought-out and insightful questions. The answers help us develop effective strategies and streamline the decision-making process. Leveraging our diverse areas of experience enables us to tailor our approach to meet the specific needs of clients and their programs. This adaptability and dedication to continuous learning ensures that we stay at the forefront of the pharmaceutical industry’s ever-evolving landscape.
Our motivation stems from a shared desire to make a positive impact in the world and assist patients. Syner-G’s Technical and QA team embodies a profound sense of responsibility and dedication to advancing the creation and production of life-saving products. By ensuring compliance, implementing effective CMC strategies, and constantly expanding our skill sets, we play a vital role in shaping the future of medicine. We are driven to create efficiencies that expedite processes, speed approvals, and have a positive impact on every stakeholder’s bottom line. Ultimately, what we strive for is to make a real difference by helping make more solutions available to healthcare providers who can then outcomes for their patients and their families.