Pharmakey
Pharmakey

Pharmakey Publishing Staff

Projects are conducted under the supervision of Mr. Robert Rohde. Mr. Rohde has a long history with Lorenz and the docuBridge publishing system. Beginning in 2004, Mr. Rohde supervised a global publishing team at Schwarz Biosciences. Using the docuBridge system, his team assembled and published eCTD applications for three new chemical entities to the FDA and EU authorities. Several hundred eCTD life cycle submissions were completed resulting in product approvals in the US and EU.

Mr. Rohde has also been responsible for a publishing team that prepared and submitted numerous IND submissions in eCTD format while working as the global director of electronic publishing at PPD. While working as a senior consultant at ESPS/Liquent, Mr. Rohde was involved in numerous electronic submission projects. He has over 30 years of experience in Regulatory affairs, 15 years working exclusively with the electronic submission process.

All of the Pharmakey publishing staff have been trained on the docuBridge system by the Lorenz training department. We use no off-shore publishing resources. Depending on the scope and timing of the submission we can bring in experienced US-based docuBridge contract publishers as well as local report/document publishers for staff augmentation.