Clinical Research Solutions
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
Quality & Compliance
Establishing Process Equivalency
A common question when transferring an established process from one facility to another is how to establish that the transferred process is performing equivalently to the original process. Sounds...
Clinical Research Solutions
Medical Writing Lean Overview
When applied rigorously and comprehensively, lean principles can reduce organizational costs while increasing productivity and strengthening the overall quality of submissions What is “Lean” as it...
Clinical Research Solutions
6 Unique Challenges Hindering Oncology Clinical Trials
The research for cancer treatment is moving forward at a rapid pace. We're witnessing a shift from chemotherapy protocols to MTAs (molecularly targeted agents) for immunotherapies in particular....
Quality & Compliance
How to Safely Launch Medical Cannabis Products in Germany
Over the past few weeks the withdrawal of cannabis products from the German market has been a topic which generated a lot of publicity. Therefore, we want to share some tips on how to safely launch...
Clinical Research Solutions
Pharmaceutical Consulting during Product & Business Development
To stay competitive in the pharmaceutical field, pharmaceutical companies need to have access to legal, product and clinical development, business strategy, and human resources experts. Startups...
Clinical Research Solutions
Three Steps Towards Complying with Nitrosamine Regulations
All Marketing Authorization Holders (MAH) of medicines for human use are facing what might feel for many, as a new requirement: review their drug products on the possible presence of nitrosamines....
FSP Solutions
5 Ways a Functional Service Provider Can Support Your Clinical Development Project
When pharmaceutical companies launch a clinical trial or reach a certain phase of Clinical Development, with only the support of their in-house employees, the additional workload often becomes too...
Quality & Compliance
Life Sciences Data Analytics: The Importance of Big Data
Big data is hitting us from all angles, and life science industries are not being left out. Why? Your life depends on it, literally. Life sciences generate lots of large and complex data every single...
Regulatory Sciences
6 Compliance Tips to get FDA Approval for Your Pharmaceutical Project
FDA Approval Process Overview The Food and Drug Administration (FDA), as part of the United States (US) Department of Health and Human Services, is the regulatory agency responsible for the review,...
Quality & Compliance
Gene and Cellular Therapies: Five Keys to Regulatory Success
We are living through a medical revolution. Advances in gene therapy, cell‑based therapies and tissue engineering offer real hope for patients with a range of debilitating diseases. The FDA, EMA and...
Deviations: Beyond the Basics
There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference between theory and practice when it...
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Quality & Compliance
FDA's Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year's Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...
Meet the Expert: Mary Speckin
ProPharma Group has launched a "Meet the Expert" series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
Quality & Compliance
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...