Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Drug Labeling Types

Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling...

Drug Labeling Types

Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?

Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions,...

Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?

Six Must-Read Scenarios for FDA Consulting

FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for...

Six Must-Read Scenarios for FDA Consulting

Third-Party Reviews for Developments Programmes

Deciding whether third party review is a favorable cost/benefit proposition for a given 510(k) development programme is not always clear....

Third-Party Reviews for Developments Programmes

Drug Product Label Advice

Drug product labelling is the primary communication tool for any drug product....

Drug Product Label Advice

FDA Expedited Development & Review Programmes Explained

FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades....

FDA Expedited Development & Review Programmes Explained

Guidance for FDA's Pre-Submission Programme

Pharmaceutical consulting and generic drug professionals: On February 18, 2014, the final guidance document was released regarding FDA's Pre-Submission programme, Requests for Feedback on...

Guidance for FDA's Pre-Submission Programme

PDG Releases New White Paper on Adaptive Clinical Trials

The value of adaptive clinical trial consulting and pharmaceutical consulting is highly correlated with up-to-date knowledge of the state of adaptive trial design....

PDG Releases New White Paper on Adaptive Clinical Trials

Medical Device Consultants on the 510(k) Program

Medical device consultants tend to take great interest in the dynamic pre-market notification (510(k) regulatory...

Medical Device Consultants on the 510(k) Program

Pharmaceutical Consultant Update on Proposed Deeming Rule and Generic CBEs

As a pharmaceutical consultant engaged in smoking cessation efforts and generic pharmacovigilance for several years, PDG has monitored two proposed rules...

Pharmaceutical Consultant Update on Proposed Deeming Rule and Generic CBEs