Pharmaceutical Development Group

Pharmaceutical Consultants and Drug Development Strategists

A Brief Summary of Seven Different 505(b)(2) Approvals

PDG® has compiled a brief summary of seven different 505(b)(2) approvals, including notable features and a tabular overview of each....

A Brief Summary of Seven Different 505(b)(2) Approvals

Types of Drug Labeling

Our most recent paper on the types of drug labeling is a useful primer for anyone with labeling or safety surveillance responsibility....

Types of Drug Labeling

How Important are Medical Device Consultants to Quality Management System Reviews and 510(k) Submissions?

Pharma consultants: Already familiar with the Quality Management System (QMS) and the benefits it has in regards to the manufacture of drugs and devices? Do you know how important it is to...

How Important are Medical Device Consultants to Quality Management System Reviews and 510(k) Submissions?

US FDA Consulting: Six Must-Read Scenarios

FDA consultants and regulatory strategists, we recognize that the space between nonprescription drugs, medical devices and prescription drugs FDA may consider ripe for Rx-to-OTC switches...

US FDA Consulting: Six Must-Read Scenarios

Benefits of FDA Third-Party Review Programmes

It is indisputable that third-party review can speed the time to market for a 510(k) and prevent RTA. On the other hand, does the money need to be spent?...

Benefits of FDA Third-Party Review Programmes

Keeping Package Inserts of Drug Products Up to Date

Your drug product labelling (aka package insert) may be out of date for a variety of reasons....

Keeping Package Inserts of Drug Products Up to Date

Explaining US FDA Development and Review Programmes

A primer for pharmaceutical consultants, our latest blog describes the characteristics, similarities, differences and applicability of each of FDA's expedited development and review programmes....

Explaining US FDA Development and Review Programmes

When to Use FDA’s Pre-Submission Programme

Pharma consultants: Did you know there is a medical device programme that is beneficial to some aspects of drug applications?...

When to Use FDA’s Pre-Submission Programme

PDG Releases Adaptive Clinical Trial Design White Paper

An adaptive clinical trial consultant or pharmaceutical consultant who writes clinical protocols will benefit by remaining up-to-date on the state of adaptive clinical trial design....

PDG Releases Adaptive Clinical Trial Design White Paper

Medical Device Consulting and the Dynamic 510(k) Regulatory Landscape

Medical device consulting in the constantly changing landscape of the 510(k) review and clearance process has always been...

Medical Device Consulting and the Dynamic 510(k) Regulatory Landscape