FDA Publishes Guidance For CAR T Products

Align your CAR T cell product development with the latest FDA guidance to ensure patient safety and compliance—embrace a systematic approach that bridges the gap between cutting-edge treatments and established standards.

How To Decentralize Cell And Gene Therapy Treatments

Rather than accepting the current standard—where patients must either travel long distances for treatment or have their tissue shipped across the globe for processing before it is returned—what if there were a better way?

The Role Of Patient Support Services In The Evolving World Of CAGTs

By offering compassionate, personalized support, we strive to make the CAGT process as seamless as possible, allowing patients to concentrate on what truly matters: their health and recovery.

Decentralization Of Cell And Gene Therapy

Through case studies, examples, and patient testimonials, readers will gain insights into how decentralization can improve patient access, enhance treatment outcomes, and facilitate innovation.

Decentralized Manufacturing And The Accessibility Of CGTs

Discover how ProPharma’s decentralization solution can streamline the delivery of cell and gene therapies, ensuring cost-effective, compliant, and local patient care.

Key Considerations For A Successful Launch In Nordic Markets

Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.

How To Create Successful Pricing And Reimbursement Of Your Pharmaceutical Product In The Nordics

Improve your understanding of the pricing and reimbursement landscape in the Nordic countries and improve your market access in the region.

FDA Drug Labeling Requirements & Regulations: What's In Your Label?

Explore the critical role of labeling and how a comprehensive approach enables alignment with clinical trial design, ensuring the label accurately reflects the product’s strengths and intended use.

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

The eSTAR template, mandatory for 510(k) submissions, simplifies FDA reviews but presents new challenges. Learn about expert support for smooth transitions and effective regulatory compliance.

Labeling Development & Intelligence

A labeling intelligence solution supports comprehensive product development, regulatory, and safety strategies, and efficient lifecycle management for successful product outcomes.

Key Considerations For A Successful Launch In Nordic Markets

Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.

Diary Of Compliance: A Year In The Life Of Ensuring FDA CAPA Standards

Acme Pharma’s journey toward FDA CAPA compliance illustrates the intricate process of aligning with stringent regulations. Learn about the progress in documentation, corrective actions, and employee engagement. 

What Is GxP Compliance: A Detective's Guide To Quality And Regulatory Compliance

Learn about GxP compliance and how it requires a culture of vigilance, robust quality management systems, continuous staff training, and collaboration with regulatory experts.

EU Pharmaceutical Legislation Revisions

The EU pharmaceutical legislation aims to balance public health priorities with industry growth, shaping a more sustainable and innovative pharmaceutical landscape in Europe.

Building Clinical Quality Assurance

Navigating the intricate clinical development process necessitates a robust Clinical & Development Quality Assurance Department to ensure adherence to health authority regulations.

What Is A Clinical Evaluation Report (CER)?

What is a Clinical Evaluation Report (CER), and how does it play a role in achieving and maintaining CE Marking under the European Union’s Medical Device Regulation (EU MDR)?

Navigating Uncertainty With The FDA LDT Rule

The FDA's Final Rule on the regulation of Laboratory Developed Tests initiated a four-year phaseout of its previous enforcement discretion. What does your lab need to prepare for the phaseout?

Clinical Research Solutions

A global team of trusted experts for multi-phase clinical development.

Functional Service Provider (FSP)

At ProPharma, we offer a unique approach to the traditional Clinical Research Organization (CRO) Full-Service Provider (FSP) model.

Improving Patient Health and Safety: Quality and Analytical Scientist

Explore how an analytical scientist enhanced quality and compliance for a pharmaceutical company by managing complex analytical testing and vendor interactions.

Defining And Implementing Global Data Standards & Governance

Discover how implementing global data standards and governance for a biopharma company, creates unified data management, standardized terminology, and a central ontology to enhance R&D efficiency.

6 Things To Consider When Selecting A Research Platform

In this article, we explore six key considerations that can help to ensure effective research platform selection and a successful digital transformation.

What Are Quality Management Systems (QMS)?

Quality Management ensures product quality and regulatory compliance through structured processes. Learn how an electronic Quality Management System (eQMS) further simplifies and enhances efficiency.

Honing Your Veeva Vault RIMS Environment For Peak Performance

Regulatory requirements are a formidable challenge for early-stage biotechs and top pharma alike. Here, we provide strategies to streamline processes, leverage data, and optimize user management.

What Is A LIMS, And How Do I Know If I Need One?

Consider these key factors when deciding if your team needs a Laboratory Information Management System (LIMS) and explore steps to optimize your biopharmaceutical development processes.

Patient Support Programs In India: Overcoming Barriers With Healthcare Access

India's healthcare system faces significant challenges in ensuring equitable access to medications. PSPs and PAPs currently play a pivotal role in addressing these gaps.

Key Considerations For A Successful Launch In Nordic Markets

Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.

Patient Assistance Programs: Bridging The Affordability Gap

Explore what Patient Assistance Programs (PAPs) are, the challenges these programs face, and how the benefits of these programs can be enhanced.

Enhancing Animal Health Compliance With Comprehensive MI And PV Services

To navigate this complex landscape of regulatory compliance, veterinary companies must implement robust MI and PV practices, ensuring the safety and efficacy of animal health products.

Enhancing Medical Information Services Through Contact Centers

As the pharmaceutical industry in JAPAC region grows, the need for efficient MI services is surging, and offshore contact centers in India and the Philippines offer a cost-effective solution.

Considerations For Implementing, Maintaining A Research Data Management Platform

Delve into the pivotal roles of people, processes, data, and technology in successful research data management platform implementation and ongoing maintenance.

Key Considerations For A Successful Launch In Nordic Markets

Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.

Enhancing Animal Health Compliance With Comprehensive MI And PV Services

To navigate this complex landscape of regulatory compliance, veterinary companies must implement robust MI and PV practices, ensuring the safety and efficacy of animal health products.

Common Challenges In Signal Detection In Pharmacovigilance And How To Overcome Them

Timely signal detection in pharmacovigilance safeguards patient safety by identifying potential drug risks. Explore support from pharma companies with strategies to improve data integration, compliance, and technological adoption.

How To Spring Clean Your PV Safety Data For Optimal Performance

Give your safety data the thorough spring cleaning it deserves to ensure accuracy, efficiency, and regulatory compliance in your pharmacovigilance processes.

Understanding The PSUR And PBRER

Stay ahead in drug safety by mastering the use of Periodic Safety Update Reports (PSURs) and their evolution into Periodic Benefit-Risk Evaluation Reports (PBRERs) to ensure ongoing public health protection.

PMA Post-Approval Study Considerations

What do you need to know about Post-Approval Studies (PAS) and maintaining ongoing compliance?

Navigating The Regulatory Maze For Medical Device Approval

Explore the critical components of clinical data assessment necessary for successful marketing applications in the medical device sector.

The Care And Feeding Of FDA PMAs

Explore the critical role of the FDA's Premarket Approval (PMA) process for medical devices, highlighting the importance of post-approval management to ensure continued compliance and market access.

FDA Finalizes Devices Program Guidance, Reinforces Manufacturers

Updated guidance from the FDA underscores its dedication to working closely with sponsors and commitment to fostering timely innovations that address critical public health challenges.

FDA Pathways To Medical Device Approval

Explore the diverse pathways available for bringing your medical device to market in the U.S. to ensure you select the optimal route for FDA approval or clearance.

Research Consulting Organization (RCO): The New Standard For Success

Over 80% of ProPharma's clinical operations team has worked on oncology trials across all of our functional groups in various capacities from full-service program management to single service support.

Clinical Development

Advisory and execution services to efficiently advance new drugs and devices to market.

ProPharma Services Overview

Whether tackling regulatory hurdles, optimizing processes, or ensuring compliance, we are committed to providing tailored solutions to meet the unique needs of life science companies at any phase of their journey.