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Explore our latest articles on pharmaceutical development, regulatory updates, and industry trends.
Navigating CMC Challenges in Antibody-Drug Conjugates
Antibody-Drug Conjugates (ADCs) are at the forefront of targeted oncology — a therapeutic class blending the selectivity of monoclonal antibodies with the potency of cytotoxic drugs. Yet, behind th...
Global CMC Regulatory Challenges: How Pharma Teams Stay Submission-Ready
The New Reality of CMC Submissions There was a time when CMC documentation felt like paperwork. You filled in templates, gathered validation data, and trusted that everything fit neatly into the Co...
From Lab to Market- Overcoming CMC Challenges in Nucleic Acid Drug Development
Introduction Nucleic acid therapeutics — including mRNA, siRNA, antisense oligonucleotides, and gene-editing platforms — are at the forefront of pharmaceutical innovation. From the rapid rollout of...
Emerging Trends in GMP Audits: How to Stay Ahead of Regulatory Change
The New Reality: GMP Audits Aren’t What They Used to Be Once upon a time, GMP audits were a fairly predictable affair. An inspection team would arrive, checklist in hand, and work methodically thro...
Why Bioassay Validation Is Getting Harder—And What You Can Do About It
Validation Shouldn’t Be the Bottleneck—But It Often Is You’re in a project review meeting. The assay team presents their final data package. Regulatory submission is just weeks away. Then it happen...
Why Biometrics Are the Backbone of Modern Clinical Trials
If you’ve worked on a clinical trial in the last decade, you’ve likely felt it: the growing weight placed on the data. Not just having it — but having it right. Traceable, standardized, analysis-re...
VHP Bio-Decontamination: Powerful, Proven — But Still Misunderstood
In cleanrooms, isolators, and advanced therapy manufacturing lines across the world, one decontamination method shows up more than most: vapour-phase hydrogen peroxide (VHP or vH₂O₂). It’s widely u...
The Hidden Costs of Poor CMO Management in Pharma
In the pharmaceutical industry, outsourcing to Contract Manufacturing Organizations (CMOs) is a double-edged sword. It promises cost savings and efficiency by tapping external manufacturing experti...
Navigating Regulatory Expectations for PK and ADA Assays in Biologics (ICH M10 and Beyond)
In biologics development, two critical analytical pillars are pharmacokinetic (PK) assays – which measure drug concentrations – and anti-drug antibody (ADA) assays – which detect immune responses a...
Why Bioequivalence and IVIVC Matter in Solid Dose Development
In drug development, there’s a moment when everything comes down to proof. You’ve spent months—sometimes years—formulating, refining, and preparing a solid oral dose. The formulation looks good on ...
A Comprehensive Overview of CMC Regulatory Requirements for Biosimilars
Biosimilars are steadily reshaping the pharmaceutical landscape by making critical treatments more accessible. However, if you’ve ever tried to develop one, you know that creating a biosimilar can ...
Dissolution Testing & Biowaivers: Key Methods & Regulatory Insights
Introduction Dissolution testing is a fundamental analytical technique in pharmaceutical development, serving as a predictor of drug release and bioavailability. It is essential for assessing the p...
The Role of PK and ADA Assays in Biologic Drug Development
Biologic drugs, such as monoclonal antibodies, gene therapies, and recombinant proteins, have transformed medicine by offering highly targeted treatments for diseases like cancer, autoimmune disord...
Excelling in Project Management for Generic: Proven Strategies for Success
Introduction In the highly competitive pharmaceutical industry, project management for generics has become a cornerstone for success. As the demand for cost-effective, high-quality generic drugs gr...
Mastering Biologics Tech Transfer: Key Success Factors
Biologics technology transfer is a pivotal process in the biotechnology and pharmaceutical industries. It bridges the gap between development and large-scale manufacturing, ensuring that cutting-ed...
CDMO vs CMO: Key Differences, Definitions, and Insights
The pharmaceutical industry thrives on collaboration, with various specialized organizations contributing to drug development and manufacturing. Among these entities, CDMOs (Contract Development an...
Extractables and Leachables: Comprehensive Approaches to Controlling
Overview of Extractables and Leachables In the pharmaceutical and medical device industries, product safety is paramount. A critical component of safety evaluation involves understanding extractabl...
Ethical Challenges and Solutions in Paediatric Drug Development
Introduction to Pediatric Drug Development Pediatric drug development is a specialized field in medical research that aims to address the unique healthcare needs of children. This process involves ...
CMC Regulatory Compliance: Key Strategies, Guidelines, Role
What is Regulatory CMC? Regulatory CMC (Chemistry, Manufacturing, and Controls) refers to the detailed documentation and oversight of the processes, procedures, and data required to ensure the cons...
The Role of CMC Statistics in Ensuring Pharmaceutical Product Quality and Compliance
In pharmaceutical manufacturing, ensuring that products meet strict quality standards is essential for patient safety and regulatory approval. One key factor that guarantees these standards is Chem...
Lipid-Based Formulations: Optimizing the Oral Delivery of Lipophilic Drugs
The development of effective drug delivery systems is crucial in the pharmaceutical industry, especially when dealing with lipophilic (fat-loving) drugs. These compounds, due to their chemical natu...
Mastering Risk Management in Medical Device Development: Key Strategies and Systems
Risk management plays a pivotal role in the development of medical devices, ensuring patient safety, regulatory compliance, and product efficacy. Without a robust risk management system, medical de...
Understanding and Controlling Bioburden: Definitions, Testing Procedures, and Best Practices
In the pharmaceutical industry, controlling bioburden is critical for ensuring product safety and compliance. Bioburden refers to the number of microorganisms present on a surface or in a substance...
Good Clinical Practice in Pharma: Understanding GCP Compliance, Regulations, and Standards for Effective Clinical Trial
In the pharmaceutical industry, clinical trials are a critical phase in the development of new drugs and treatments. These trials ensure that new medical interventions are safe and effective before...
Process Validation in Pharmaceutical Industry
Process validation is a crucial part of making medicines. It ensures that the products are always made to high standards and follow all the rules. This involves a detailed and organized method to p...
Extractables and Leachables Testing
Extractables and Leachables Testing: Ensuring Safety and Compliance in Pharmaceutical Packaging In the pharmaceutical and medical device industries, the safety and effectiveness of products are cru...
What is the Difference between GLP and GMP
Comparing GLP vs. GMP: Understanding Key Distinctions in Laboratory Testing Regulations When navigating the complex landscape of laboratory testing and pharmaceutical production, two terms often ar...
Let’s Talk About Pharma | Inhalation Drug Products: Insights into Development, Challenges, and US & EU Regulatory Standards
There are several inhalation drug products available on the market. All of them have some advantages and disadvantages. Based on your opinion, which is the best for the end-user-patient? The best d...
What is CMC in Pharma?
What does CMC stand for in pharma? In the pharmaceutical industry, the acronym CMC stands for Chemistry, Manufacturing, and Controls, a triad of interconnected elements that form the backbone of dr...
Let’s Talk About Pharma | CMO: Successful Outsourcing, KPIs & Supplier Relationship
Why long-term strategy is so important for successful outsourcing of clinical and commercial activity? Outsourcing clinical and commercial activity is a key strategic decision for an organisation. ...
Phases of Drug Development Process
Definition of Drug Development Drug development refers to the systematic and highly regulated process of creating new pharmaceutical compounds or therapies for the treatment, prevention, or managem...
Understanding GxP Regulations in Pharma
What is GxP? GxP meaning: an abbreviation for “Good [anything] Practice,” represents a set of quality and regulatory standards that are paramount in the pharmaceutical and healthcare industries. Th...
Strategic Decision-Making in Pharma: Training for Success
In the pharmaceutical industry, strategic decision-making is a linchpin for success. This topic, “Strategic Decision-Making in Pharma: Training for Success,” delves into the essential strategies an...
Let’s Talk About Pharma | Real World Evidence: Why It's Important & What's The Future
In regulating and authorizing medicine, what’s the role of RWE in FDA and EMA approvals? Nowadays, both FDA and EMA use RWE extensively in their regulatory decision-making. A recent analysis showed...
What is Clinical Investigations and Evaluation
What is Clinical Investigations? Clinical investigations are an integral aspect of modern healthcare, playing a pivotal role in diagnosing and treating various medical conditions. This systematic p...
Latest Requirements for Aseptic Manufacturing of Pharmaceutical Products
Increased demand for sterile filling The shift from ‘blockbuster’ pharmaceutical products towards biological products and advanced therapies that provide more targeted modes of action is acknowledg...