Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Huge New Opportunity in Generic Drug Development Created by US FDA

The US market is to gain access to previously unavailable therapeutically equivalent generic drug formulations due to a number of changes....

Huge New Opportunity in Generic Drug Development Created by US FDA

Breaking Down Complex Generics

Pharmaceutical consulting and generic drug professionals: What is your hedge against the increasingly crowded traditional drug markets?...

Breaking Down Complex Generics

Explaining Biosimilars

Pharmaceutical consulting and generic drug professionals: What is your hedge against the financial risk associated with increasingly crowded traditional drug markets?...

Explaining Biosimilars

Gaining an Understanding of Pharmacokinetic Protocols

Engaged in pharmaceutical consulting, the scientists and regulatory professionals at PDG® are tasked with design of pharmacokinetic (PK) protocols for a wide variety of applications....

Gaining an Understanding of Pharmacokinetic Protocols

Examples of 505(b)(2) Applications

Pharmaceutical consulting and generic drug professionals: What are you doing to circumvent the increasingly crowded traditional drug markets?...

Examples of 505(b)(2) Applications

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