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.

Advice for First Time NDA/BLA Submission Teams

Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found that the most exciting projects to work on are...

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Regulatory Medical Writing: Who is your audience?

Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing project.  Regulatory medical writers...

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How to Choose a Partner to Optimize INDs

Biopharmaceutical development is an extensive and complex process. Managing processes like Investigational New Drug (IND) applications or the manufacturing, quality, and regulatory side of the processes—collectively known as CMC, or the Chemistry, Manufacturing and...

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Four Top Roadblocks to Successful IND Applications and How to Overcome Them

Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise within their teams. One such process is the Investigational New Drug (IND) application with the Food and Drug Administration (FDA).

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Unlocking the Potential: The Power of Drug Repurposing in Modern Medicine

Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization. Drug repurposing, also known as drug repositioning paves an alternate path for drug development which involves identifying new therapeutic indications or uses for the existing molecules that could have been initially approved for or have clinically failed in a different indication. The success rate for new drugs to reach the market is approximately only 10% whereas about 30% of repurposed drugs get regulatory approval.

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Formulation Strategies for Large Molecule Drug Products

Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.

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Ensuring Aseptic Technique: Use of Isolators

By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to...

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