July 13th, 2020 by aveciapharma
Pharmaceuticals are undoubtedly an extremely R&D intensive when compared to most other industries. As the process of producing new drugs is not only a time-consuming and costly endeavor but also has deadlines to meet. That’s why when presented with these challenges, pharmaceutical companies seek...
Posted in: Services
March 13th, 2019 by Adam C. Fox
By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence...
Posted in: BioProcess Online, Outsourced Pharma
March 5th, 2019 by aveciapharma
Nitto Avecia Pharma Services is a FDA inspected cGMP contract development and manufacturing organization supporting the pharmaceutical and biopharmaceutical industries from early phase through post-market life cycle management. With a state-of-the-art facility, experienced staff, and robust quality...
Posted in: Pharmaceutical Online
February 14th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Nitto Avecia Pharma Services Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry,...
Posted in: Pharmaceutical Online
February 5th, 2019 by Adam C. Fox
By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services Why is this service needed? Many new delivery systems and drug-device combinations make dosing less cumbersome for patients and healthcare providers. But they add more complexity for drug developers....
Posted in: Pharmaceutical Online