Generic Drug Development: 505(j) ANDAs and Potential Diversification
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
The industry professionals at PDG conduct high quality international Literature search services across a variety of medical and scientific databases. Customized and Targeted Literature Search Services In providing Literature search services, PDG employs customized and targeted search methods, summary and analyses, extensive electronic library and multi-lingual translation options. Our methods are highly cost-effective and routinely…
As regulatory strategists, our view of non prescription drug Product development (aka Over-the-Counter or OTC) certainly includes new OTC launches and Rx-to-OTC switches. However, there are many lesser known nonprescription OTC drug development opportunities that PDG can help with. Click through these four Q&As to learn more. As you do so, keep in mind…
Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product.
International and U.S. companies rely on the expertise and professional resources of PDG to provide dependable, accurate and compliant drug safety programs, pharmacovigilance services and ongoing assessments of labeling accuracy and completeness. An Experienced Post-Marketing Safety Surveillance Team PDG’s array of epidemiologists, clinicians, statisticians, and regulatory experts deliver evidence-based analyses to address the safety and…
Our team of full time professional staff and expert consultants are well-versed in the nuances of professional and promotional labeling including website review.
Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time.
In our capacity as a pharmacokinetic consultant to both ANDA and NDA sponsors, PDG has participated in all phases of the regulatory and development processes.
For over 15 years, PDG has helped pharmaceutical firms achieve and maintain compliance with global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and pharmacovigilance (PV) standards.
PDG assists the pharmaceutical industry to develop and maintain prescription and non-prescription drug products and devices. Not surprisingly, we engage in a variety of regulatory activities involving literature searches and data evaluations to accomplish these tasks. On any given day you might find our staff developing Pre-IND/NDA meeting packages, developing FDA correspondence and regulatory submissions,…