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Clinical Research Solutions
Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...
Clinical Research Solutions
Introduction A key prerequisite activity for any successful process validation is process characterization. Process characterization involves varying process inputs such as raw material properties,...
Clinical Research Solutions
My last blog focused on the industry trends concerning cleaning validation verification. Through a quick poll we found that out of twenty-three respondents, approximately fifty (50) percent are doing...
Clinical Research Solutions
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Clinical Research Solutions
Recently I was asked by a client whether they should continue to do Re-Qualifications or change to Continued Process Verification on their qualified cleaning circuits. To answer this, the factors to...
Clinical Research Solutions
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...
Clinical Research Solutions
When a biopharmaceutical company builds new or renovates existing manufacturing space, the last consideration before turning the production key is the environmental monitoring of the same. This short...
Clinical Research Solutions
On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings...
Clinical Research Solutions
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...