Pharmaceutical Development Group

Pharmaceutical Consultants and Drug Development Strategists

What is a Biosimilar and How Does it Differ Compared to Drug Development?

Prior to 23 March 2010, there was no regulatory pathway for biosimilar development in the US....

What is a Biosimilar and How Does it Differ Compared to Drug Development?

A Summary of Pharmacokinetic Principles for ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists at PDG are also pharmacokinetic (PK) consultants. Proper design and placement of your PK studies is critical....

A Summary of Pharmacokinetic Principles for ANDA/505(b)(2) Submissions

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

According to the guidance, a 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval 'were not conducted by or for the applicant and...

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Your drug product labelling (aka package insert) may be out of date for a variety of reasons....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