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Transitioning from early-stage research to clinical development is one of the most critical and complex phases in the drug development

The pharmaceutical industry is undergoing rapid transformation, driven by innovation and technological advancements. However, as the competitive landscape intensifies, pharmaceutical

In the United States, medical devices are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and their

Sterilization of medical devices is a cornerstone of patient safety, preventing healthcare-associated infections (HAIs) by eliminating harmful microorganisms. Medical devices,

Monitoring medical device clinical trials is a critical aspect of ensuring the safety, efficacy, and regulatory compliance of devices before

The In Vitro Diagnostic Regulation (IVDR) represents a significant overhaul of the regulation for in vitro diagnostic (IVD) medical devices

In clinical trials, particularly those focused on cancer, outcome variables often involve date data, such as progression-free survival (PFS) or

Meta-analysis is a powerful tool used in clinical research to aggregate and synthesize data from multiple studies, offering a more

Leveraging AI in Medical Devices: Challenges and Opportunities in Healthcare Technology  Artificial Intelligence (AI) is revolutionizing the healthcare industry, particularly

The development of treatments for rare diseases has long been plagued by hurdles like limited patient populations, diverse treatment responses,

Vaccines have played a crucial role in global health, providing life-saving protection against a wide range of infectious diseases. Vaccines

In the ever-evolving biopharma market, change is inevitable. What we are witnessing today is a transition of an entirely different

For oncology product developers, preparing for an FDA Advisory Committee (Ad Comm) meeting is one of the most critical steps

Patient support services have evolved from being a supplemental offering to a core component of comprehensive patient care in the

Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies (CGTs), hold the remarkable potential to offer personalized treatments for

In today’s regulated pharmaceutical landscape, data integrity is paramount. Whether you are preparing for an internal or external audit, ensuring

As the leader of a project, you know that seeing a new initiative go to completion—requires careful planning and execution.

Facing a pending filing and subsequent Pre-Approval Inspection (PAI) can feel overwhelming, whether you’re a young firm or an established

As clinical trials for rare diseases evolve, the need for patient-centric care has become a focal point in ensuring participant

Receiving an FDA Form 483 observation is a serious matter for any company in the regulated industries such as pharmaceuticals,

IMP (Investigational Medicinal Products) Supply Chain Management plays a pivotal role in ensuring the right drug reaches the right patient

Being inspected by the U.S. Food and Drug Administration (FDA) can be a stressful experience, especially if the outcome is

The Importance of Gap Assessments in Accelerating Success in Life Sciences  Are you struggling with persistent deviations, inefficient processes, or

Switching from a traditional paper-based Quality System to an Electronic Quality Management System (EQMS) can be an intimidating task, but

In a fast-evolving regulatory environment, staying compliant and ahead of the curve is no easy feat. The pressures to meet

In the world of life sciences, ensuring the accuracy and reliability of your data is not just important—it is critical.

In industries where compliance is paramount, maintaining quality is not just important—it is critical. While traditional paper-based Quality Management Systems

The role of computer software in the biotechnology and medical industries has become indispensable. Advanced technological solutions allow researchers, scientists,

In any business, meeting customer requirements and enhancing satisfaction is crucial. But for organizations in highly regulated industries like life

Bringing a medical device to market in the U.S. is a multi-step process that requires understanding the appropriate regulatory pathway

In today’s fast-paced, data-driven world, the integrity of our data is more crucial than ever, especially when transitioning to new

In late 2020, the FDA introduced a draft guidance on Computer Software Assurance (CSA) for manufacturing, operations, and quality system

When it comes to managing laboratory results, data integrity is key. But what happens if your results do not match

The role of computer software in the biotech and medical industries is increasing day by day. With the rapid advancements

In any organization, managing Quality Documents (QDs) effectively is essential to operational efficiency and compliance. While there are many reasons

In both our personal and professional lives, risk assessments play a crucial role. From choosing a safe car for a

What is a Validation Master Plan (VMP)?  A Validation Master Plan (VMP) is a critical document in the pharmaceutical and

In the fast-paced and highly regulated life sciences industry, staying ahead of the competition and managing complex projects can be

What is Computer System Validation (CSV)?  Computer System Validation (CSV) is a critical process in regulated industries that ensures a

In the ever-evolving life sciences industry, the integration of cloud-based software into business operations is revolutionizing how companies manage their

In the Life Sciences Industry, calibration and validation are two of the most important regulatory requirements to ensure the accuracy,

The pharmaceutical industry is known for its large, complex projects that require meticulous planning, coordination, and execution. The ultimate goal

Successfully Wrapping Up Your Inspection: Best Practices In this final article on inspection success, we will cover the essential steps

The Critical Role of Validation in Pharmaceutical and Biotech Manufacturing Validation is a cornerstone of quality assurance in the pharmaceutical,

Ensuring Efficient Computerized Systems for cGxP Compliance  In today’s regulated environments, computerized systems are crucial for ensuring cGxP (current Good

In industries like pharmaceuticals, biotechnology, and healthcare, maintaining critical plant systems such as reverse osmosis and chemical distribution is vital.

A Complete Guide for Achieving ISO 17025 Accreditation Are you a laboratory that performs sampling, calibrations, or testing? If so,

In our ongoing blog series on regulatory affairs inspections, we have emphasized the importance of making a positive first impression

Change is inevitable, especially within industries governed by stringent regulatory standards like pharmaceuticals and medical devices. Whether it is adapting

Since the publication of ICH Q9 “Quality Risk Management”, applying its principles within Pharmaceutical Quality Systems has become an essential

Understanding and Managing Deviations in Pharmaceutical Manufacturing: A Guide by BioBoston Consulting In pharmaceutical manufacturing, maintaining strict adherence to established

Ensure GMP Compliance with Expert Data Migration Services   In the highly regulated pharmaceutical and medical device industries, ensuring data integrity

Maximize Your Pharma/Biopharma Risk Assessment with Expert Guidance  Risk assessment is a cornerstone of quality management in the pharmaceutical and

Ensure Accurate Document Review   In pharmaceutical and biopharmaceutical manufacturing, the accuracy of documents such as batch records, qualifications, validations, calibration

Ensure GMP Compliance with Expert Documentation   In the pharmaceutical and medical device industries, maintaining meticulous records is not just a

Maximize Your Company’s Performance with Expert Quality Metrics Solutions  Understanding how your company is performing is essential for continuous improvement.

Ensure Strong Quality Assurance with Expert Support  The Quality Assurance (QA) department is the backbone of any GMP-compliant company. QA

Ensure GMP Compliance Expert Guidance  Is your company fully compliant with Good Manufacturing Practices (GMP)? Or are you in the

Ensure Compliance and Pass FDA Audits with Expert Internal Audit Services  Preparing for an FDA audit requires meticulous attention to detail

In pharmaceutical and biopharmaceutical manufacturing, ensuring product quality and patient safety is paramount. The identification and verification of Critical Aspects

In today’s pharmaceutical and biopharmaceutical industries, Commissioning and Qualification (C&Q) activities play a pivotal role in achieving and maintaining a

BioBoston Consulting offers eQMS software solutions to streamline quality management, improve regulatory compliance, and boost performance in the biotech and

Partner with BioBoston Consulting to develop a winning regulatory strategy for your life sciences product. From drug approval to post-market

Explore BioBoston Consulting’s expert services in life science solutions, including CQV, CSA, and advanced software tools. Drive innovation, improve compliance,

Discover BioBoston Consulting’s expert metrology and calibration services for the life science industry. Ensure accuracy, compliance, and operational success with