Drug Monitoring and Safety: Always an Important Management Concern; Now More So
16 May 2016
Safety surveillance and pharmacovigilance consulting to generic drug manufacturers, as well as generic drug labelling consulting may soon become a service in demand.
Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design
15 Jan 2016
Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.
Medical Device Consultant on 510(k) Submissions
08 Oct 2015
As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.
Drug Labeling Specialist on New Pregnancy Labeling Rules
01 Jul 2015
On June 30 2015, the new pregnancy labeling rules for prescription drug labeling took effect, marking the demise of pregnancy categories (A, B, C, D, X), in use since 1979.
Experienced Accessible Pharma Professionals and Global Regulatory Services
30 Apr 2015
PDG® has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals ...
All Roads Lead to the 505(b)(2)
30 Apr 2015
Innovators are forced to re-evaluate traditional business models, due to decreasing R&D output, billions of dollars in patent expirations and increasing generic competition.