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Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50 regulatory authorities for 31 different countries, making it difficult to...
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...
Use this readiness questionnaire to assess the current state of your progress.
A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...
Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? You are in the process of obtaining an MA or CTA to bring your product to EEA/UK markets, which can be a complex...
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
A global medical device company asked ProPharma Group to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined...
As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...
Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...
Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...
Learn how ProPharma helped implement and execute decentralized visits for a pediatric rare disease study. The COVID-19 pandemic caused major disruption to many clinical trials and the participants...
Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...
Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...
Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study. ...
AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!
Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma Group used their deep...
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.
With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.
Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. ProPharma Group’s team of Regulatory Sciences...
How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. You’ve developed a novel drug and obtained FDA approval. Your work is done, right? Not if...
Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!
One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...
Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...
Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...
In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...
When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...
A routine safety letter to HCPs was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety letter to healthcare...
Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...
Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...
Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...
See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...
Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...
Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...
Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients
Regulatory Agencies Expect Controls to Be in Place
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...
Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...
Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...
Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...
There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...
How to avoid getting your first, second, and third warning letter from a federal agency.
Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...
Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...
Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. Coupled with new processes and procedures within a company that has a...
Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...
Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...
There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...
With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
Navigate Complex Global Requirements for Medical Device Approval
Reduce Launch Timeline and Improve Business Efficiency
Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...
Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...
Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...
See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. An emerging Biotech Sponsor needed management and full-service...
Ensuring accurate and honest data collection is essential for maintaining the integrity of research. Even though the right mindset is the start of data integrity compliance, that alone is not enough...
Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...
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