ProPharma Group, LLC

ProPharma Group, LLC

ProPharma Group is an industry leader serving the compliance needs of the pharmaceutical, biotechnology and medical device industries.  The experts at ProPharma Group enable our customers to achieve continuous compliance and improve their operations in a complex and changing regulatory environment. 

Our clients choose us because of our seasoned professionals, expertise, and the practical solutions we provide.  They stay with us because we understand what it takes to deliver a project in-budget, on time, and in compliance. 

We offer a wide array of services to meet our clients' many needs.  Our services include:

  • Compliance and Quality Assurance

  • Commissioning and Qualification

  • Computer Systems Validation

  • Process Validation and Cleaning Validation

  • Program Management

  • Project Management

  • Technology Transfer and Drug Device Development

  • Medical Information Services

  • Corporate Compliance

Your trust means everything to us.  Call our experts at 888-242-0559, or visit us at

ProPharma Group, LLC

 •  October 18, 2017

A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization great. Not average, not pretty decent, but GREAT. The following two part blog is the narrative of that presentation. I’ve also included references to some...

ProPharma Group, LLC

 •  October 13, 2017

Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017.If you don’t want to review the entire guidance, here are the topics, although keep in mind there may be broader application and expectation. Also remember, these are comments on a draft guidance that is yet...

ProPharma Group, LLC

 •  September 29, 2017

A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to implement and manage compliant and risk-based approaches to aseptic process simulation studies (APS), commonly referred to as media fills. The following are typical observations:Your media fill studies do not closely...

ProPharma Group, LLC

 •  July 6, 2017

In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industry for failing to thoroughly review or investigate issues. This topic consistently hits the top five most frequent observations cited year after year. What is it about the investigation process that so many organizations are struggling with?One pitfall that I see...

ProPharma Group, LLC

 •  June 29, 2017

The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters, and consent decrees. Regulatory agencies, such as the FDA, rely on data to ensure the safety and efficacy of drug products—and this data must be beyond...

ProPharma Group, LLC

 •  May 23, 2017

Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings involving the reliability and trustworthiness of data. Expectations for ensuring data integrity are evolving and increasing. The rise in 483 observation...

ProPharma Group, LLC

 •  February 24, 2017

About 10 years ago, I was a project management director responsible for moving monoclonal antibodies (MABs) from Phase III clinical to commercial manufacturing. I had the distinct pleasure of working on two new molecular entities (NMEs) at a top-tier biotech company with currently marketed products treating rheumatoid arthritis and plaque...

ProPharma Group, LLC

 •  February 22, 2017

The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has been achieved is through the collection and analysis of data. But generating process data is expensive. Immediate costs include materials, process,...

ProPharma Group, LLC

 •  February 7, 2017

The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No. 56: Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance). The FDA-harmonized guidance is welcome news to organizations involved along the drug...

ProPharma Group, LLC

 •  January 20, 2017

The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA does its work. Although the news headlines have featured the large funding of the Cancer Moonshot and the bolstering of FDA staff and resources, key...