Category Archives: News

Are you ready for Electronic DMF?

eCTD will become mandatory for Drug Master Files in May 2018. What does this mean for your Type III DMF packaging material file? PharmaLex gives advice on converting current content into the new structure. Download our whitepaper to learn more. Download link will appear once form is submitted. Download works best on IE, Mozilla Firefox and […]

FDA Meetings – How to get the best advice- Free Download

Periodic and timely meetings with the FDA have shown to increase the probability of a rapid market approval and can have a direct impact on development costs. But how do you get the best advice? We have prepared a quick guide for you.  Download free…. Download link will appear once form is submitted

PharmaLex Pharmacovigilance Experts provide client project case study highlighting importance of database selection in observational research – Download Free

This article highlights the importance of database selection in observational research and to determine the incidence of corticosteroid-related events in patients exposed to fluticasone propionate intranasal spray (FPNS) compared with other intranasal steroids (INS).  Degge, a member of the PharmaLex group, conducted a retrospective cohort study using a large administrative claims database in the USA from […]

PharmaLex US experts review FDA – EU authorities’ Mutual Recognition Agreement

During March 2017 the FDA and EU authorities signed the Mutual Recognition Agreement, an amendment to the annex for Good Manufacturing Practice (GMP) to the broader US – EU Mutual Recognition Act previously signed in 1998.  This update will allow the FDA to recognize drug manufacturing site inspections conducted by other global authorities. Download this complimentary […]

PharmaLex US client, Toleranzia AB, receives orphan drug designation from FDA

PharmaLex US was recently pleased to deliver exciting news to our client in Sweden, Toleranzia AB, that their orphan drug designation request that we had collaborated on together for their experimental myasthenia gravis medication had been approved for orphan status by the FDA! Reach out and ask how we can help advance your projects with […]

PharmaLex US receives ISO 9001:2015 certification

ISO 9001:2015 certification awarded to PharmaLex US PharmaLex US received ISO 9001:2015 certification on February 19, 2017. As a requirement of the certification PharmaLex US voluntarily adheres to the internationally known set of standards developed by ISO (International Organization for Standardization) addressing various aspects of quality management.  These standards are based on a number of quality management principles including a […]

PharmaLex Group adds Pharmacovigilance to its service portfolio in the US

The addition of this service allows the Group to drive its specialist drug safety expertise within the US. As of 17th January, 2017, the PharmaLex Group, a leading provider of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has enhanced its service portfolio in the US with the addition of an industry leader in the […]

CTD expectations – CMC differences between the United States and Europe

Differing regulatory requirements exist between regions and countries.  PharmaLex US experts breakdown the general  differences that exist between the CMC requirements imposed by the FDA and the regulatory authorities in Europe. Please enter your name and email address then click on the link that appears below to download the white paper with our compliments. Link […]