Meranda Parascandola

June 13, 2024
Published by Meranda Parascandola at June 13, 2024

What CDRP Means in Chemistry, Manufacturing, and Controls

Chemistry, manufacturing, and controls (CMC) is a critical aspect of drug development, ensuring new medications' quality, consistency, and safety. However, the lengthy approval process, which can take 10-15 years, increases expenses and limits patient access to novel therapeutics. The CMC Development and Readiness Pilot (CDRP) program aims to address this […]
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July 3, 2024
Published by Meranda Parascandola at July 3, 2024

Can Chemistry, Manufacturing, and Controls Consulting Pave the Way for New Tech?

Developing new pharmaceutical technologies and drugs is a complex and multifaceted process. A critical component that can determine a new drug's success or failure is the Chemistry, Manufacturing, and Controls (CMC) strategy. CMC consulting plays a pivotal role in translating a drug's target profile into an actual product by defining […]
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July 11, 2024
Published by Meranda Parascandola at July 11, 2024

The path to perfection: A deep dive into continuous improvement in quality management

What principle does DSI prioritize for continuous improvement for quality management? How do these principles contribute to the advancement of quality management systems? Continuous improvement is an industry expectation. If you are using quality management systems on a daily basis, it is important to keep up with changes and trends […]
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July 18, 2024
Published by Meranda Parascandola at July 18, 2024

How CMC Drug Development Differs within Veterinary Medicine

The costs of developing a new medication can amount to over $1 billion, depending on the complexity of the drug and expenses associated with unsuccessful studies. With these costs in mind, an optimized regulatory process is required to ensure that the procedures behind drug development are secure, safety-oriented, and reliable. […]
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July 26, 2024
Published by Meranda Parascandola at July 26, 2024

Understanding Global Harmonization of Regulatory CMC for Animal Health

Animal health depends upon veterinary medicine. Developing new medications not only safeguards animals from various diseases and conditions, but also helps prevent the transmission of zoonotic illnesses to humans. Central to this development is regulatory CMC (Chemistry, Manufacturing, and Controls), which focuses on the composition, manufacturing practices, and quality of […]
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July 26, 2024
Published by Meranda Parascandola at July 26, 2024

DSI to Attend Animal Health Corridor Summit in Kansas City, MO on August 26-27th

Date: July 26, 2024 Location: Kansas City, MO DSI, a renowned pharmaceutical and animal health industry leader, is thrilled to announce its participation in the upcoming Animal Health Corridor Summit on August 26-27, 2024. This summit is a pivotal event for industry leaders, offering a platform for innovation, collaboration, and […]
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September 26, 2024
Published by Meranda Parascandola at September 26, 2024

Navigating CMC: Key Lessons from Industry Leaders on Ensuring Success in Drug Development

Discover key strategies for mastering CMC in drug development from industry leaders. Our blog covers expert insights on early-stage de-risking, CMO selection, and leveraging AI to drive success.
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October 16, 2024
Published by Meranda Parascandola at October 16, 2024

ProductLife Group (PLG) Acquires Halloran

ProductLife Group (PLG), a trusted global leader in regulatory, scientific, compliance, and digital transformation consulting services for the life sciences, today announced the acquisition of Halloran Consulting Group, a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support in the pharmaceutical, biotechnology, and medical device sectors in the United States, further positioning PLG as a leading global provider of comprehensive healthcare services.
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October 17, 2024
Published by Meranda Parascandola at October 17, 2024

5 Key Benefits of Biopharmaceutical Consulting

Improve your pharmaceutical product’s chances of success by engaging a biopharmaceutical consultant. These specialists offer essential expertise in drug development, clinical trial design, regulatory compliance, and market strategy. Their deep industry knowledge helps you make informed decisions, avoiding costly pitfalls, and accelerating your path to market. By benefiting from their […]
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October 23, 2024
Published by Meranda Parascandola at October 23, 2024

Understanding QP Certification & Batch Release

Quality, safety, and efficacy are core tenets of pharmaceutical manufacturing. One critical component of this assurance process is batch release. This is a meticulously controlled procedure overseen by a Qualified Person (QP). Our blog aims to elucidate the nuances of QP certification and batch release within the European Union (EU), […]
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