Syner-G BioPharma Group Blog
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News & Resources for Pharmaceutical, Biotech, Healthcare, Medical & Life Science. Exclusive Content from Pfizer, GSK, AstraZeneca, Novartis, Wyeth & more IMPACT is a Contract Research Organization in RTP, NC that provides a range of drug development services for the Pharmaceutical and Biotech industries.
Syner-G BioPharma Group Blog
2w ago
Patients with serious or life-threatening conditions often face limited treatment options, and waiting for new therapies can take years. The Breakthrough Therapy Designation (BTD) helps accelerate this process for drugs that show strong early evidence of being more effective than ..read more
Syner-G BioPharma Group Blog
2w ago
Bringing a new drug to market is a long and highly regulated process designed to ensure safety, efficacy, and quality. The pharmaceutical drug development process moves through multiple stages—beginning with drug discovery, advancing through preclinical and clinical research, and ultimately ..read more
Syner-G BioPharma Group Blog
2w ago
Navigating the FDA regulatory action process presents unique challenges, and unexpected setbacks can stall even the most promising development programs. FDA Type A Meetings provide sponsors with an opportunity to obtain regulatory advice and timely feedback on critical issues affecting ..read more
Syner-G BioPharma Group Blog
1M ago
Sujata Kulkarni Why did you choose a career in biopharma? Growing up, I didn’t have the option to pursue medicine due to various reasons, so I had to select a field that aligned with my interests. This is when my ..read more
Syner-G BioPharma Group Blog
1M ago
Cell and gene therapy development has entered a transformative era, bringing unprecedented challenges and opportunities in Chemistry, Manufacturing, and Controls (CMC). As these revolutionary treatments progress from clinical trials to commercial manufacturing, the future of CMC in cell gene therapy ..read more
Syner-G BioPharma Group Blog
1M ago
A strong CMC strategy is crucial for biotech startups moving into clinical trials. Regulatory agencies expect detailed documentation to confirm a drug’s safety, consistency, and quality, which means early planning can prevent costly delays. Startups that take a proactive approach ..read more
Syner-G BioPharma Group Blog
1M ago
The biopharmaceutical industry stands at a pivotal intersection of regulatory evolution and technological advancement. Companies that successfully adapt to these changes while maintaining robust compliance frameworks will be best positioned to deliver innovative therapies to patients safely and efficiently. ..read more
Syner-G BioPharma Group Blog
1M ago
Stability studies are essential to pharmaceutical development, providing the data needed to make sure drugs remain safe and effective throughout their shelf life. These studies evaluate how environmental factors like temperature, humidity, and light impact a drug’s quality over time ..read more
Syner-G BioPharma Group Blog
3M ago
What is process control? Process control is the backbone of precision in manufacturing, providing the framework needed to maintain quality, safety, and efficiency. In the biopharmaceutical industry, even minor deviations can have significant consequences; process control plays a vital role ..read more
Syner-G BioPharma Group Blog
3M ago
The submission of an IND or other global first-in-human regulatory filing represents a pivotal milestone in transforming scientific discoveries, known as new chemical entities, into potential medical breakthroughs. This process involves a comprehensive evaluation of drug candidates to ensure their ..read more