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May 23, 2019
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   Overcoming Analytical Compliance Challenges

Given the need for accurate analyses to ensure the quality, safety and efficacy of drug products that reach the marketplace, analytical method development and validation compliance requirements are both extensive and stringent. They also continually evolve as new types of therapies and advances in analytical technologies are introduced. CDMOs that implement strategies for facilitating analytical method development and validation in anticipating evolving compliance requirements help their customers reach the market sooner while leveraging a more secure supply chain.

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» Industry News
 
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» Featured Articles
Right-Sizing Technologies for Early Clinical Development
We all love technology…right? Some of us will camp outside the Apple store for the next iPhone or rapidly adapt to the next gaming device or streaming capability. It is exciting to embrace new ... read more »
Integrated CDMO and CRO Services Creates Innovation in Early-Stage Drug Development
The pharmaceutical research and development (R&D) industry has changed significantly over the last decade. In particular, big pharma is transitioning to a leaner business model that relies heavily on ... read more »
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» Featured Video
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  Watch Video: A Discussion with Dr. Thomas Page, VP Engineering and Asset Development at Fujifilm Diosynth Biotechnologies
Watch Video: A Discussion with Dr. Thomas Page, VP Engineering and Asset Development at Fujifilm Diosynth Biotechnologies read more »
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  Watch Video: A Discussion with Andy Topping, PhD CSO from Fujifilm Diosynth Biotechnologies
Watch Video: A Discussion with Andy Topping, PhD CSO from Fujifilm Diosynth Biotechnologies read more »

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» Featured Whitepaper
Considerations for Development of a Lyophilized Biosimilar
The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. This provides ... read more »
Proceed With Confidence. Understanding Your Molecule’s Full Potential During Proof of Concept
Demonstrating your molecule's proof-of-concept (PoC) is an important developmental milestone. If you can show compelling and valid data supporting ... read more »
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| Events
EVENT
  Clinical Trial Supply Southern California
Del Mar, CA –  06/05/2019
Facilitating a platform for the San Diego biotech hub to refine their clinical trial supply strategy to remain patient focused whilst staying at the ... event details »
EVENT
  3rd eRegulatory Submissions Summit
Philadelphia, PA –  07/09/2019
The 3rd eRegulatory Submissions Summit will cover changes made to the electronic submission processes and protocols for constructing strategies for ... event details »
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