Blog
All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.
Personalized Medicine Requires a New Approach to Quality Control
Personalized medicine is truly that. Based on an individual's unique genetic profile, it’s used to make precise decisions according to that person’s biologically predetermined factors, and guides the optimum approach to disease prevention, diagnosis, and treatment. It...
3 Critical Keys to Expediting CMC Development
Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering with experts.
What Does Syner-G’s Technical and Quality Assurance Team Do?
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.
Don’t Fear the Cost of Preparedness in Becoming a Reliable Supplier
How AI and ML can facilitate quality improvements in biopharma Artificial Intelligence (AI) and Machine Learning (ML) are often confused, but they are fundamentally different. AI comprises pre-built products that use established patterns for recognition and...
Empowering and Encouraging Innovation: The Advantages of the FDA’s Orphan Drug Designation for Drug Companies and Patients
It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since its passage in 1983, the Orphan Drug Act has helped countless individuals living with rare diseases receive...
Overview of FDA Expedited Development and Approval Programs for Serious Conditions
May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and...
The Push for Patient-Focused Drug Development
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. As professional drug development...
Keep ’em Coming: An Overview of IND Updates
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of...
From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing - congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing may...
Statistics in Harmony: The Role of Estimands in Regulatory Writing
February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical...
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