ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
Clinical Research Solutions
Regulatory and Procedural Guideline May 2022 EMA/CVMP/678496/2021-rev Introduction “According to Article 37(5) of Regulation (EU) 2019/6 (‘the Regulation’), the European Commission shall adopt...
Clinical Research Solutions
June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...
Clinical Research Solutions
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...
Clinical Research Solutions
Guidance Document Guidance for Industry and Food and Drug Administration Staff JUNE 2022 This guidance document provides FDA's recommendations on the information, technical performance assessment,...
Clinical Research Solutions
Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...
Clinical Research Solutions
Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...
Clinical Research Solutions
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
Clinical Research Solutions
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
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...
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...
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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...