In previous guidance, the FDA (both CDER and CBER) has noted its clear interest in promoting electronic submissions, including eINDs, in the eCTD format as early as possible in the development process.


A web-based electronic Document Management and eSubmission Solution

PharmaReady

09
Jun2017

Life Sciences expert Navitas augments end-to-end capabilities

Navitas, a technology-led Life Sciences services provider across Clinical, Regulatory and Safety, announced that it would be...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures ingredients for global...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the...

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules...

16
Oct2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ...