BLOG

Integrating cGMP in Clinical Manufacturing

Integrating cGMP in Clinical Manufacturing

Quality and safety are of utmost importance, among other critical…

Essential ANDA Checklist: Key Steps to Streamline Your Filing Process

Essential ANDA Checklist: Key Steps to Streamline…

Abbreviated New Drug Applications (ANDAs) are submitted to the FDA…

What is Oral Solid Dosage (OSD): A Comprehensive Guide to OSD Formulations

What is Oral Solid Dosage (OSD): A…

Oral solid dosage (OSD) refers to a finished drug product…

Why Your Early-Stage Drug Development Needs an R&D-Focused CDMO Partner

Why Your Early-Stage Drug Development Needs an…

Early-stage drug development is best performed at an R&D-focused CDMO.…

From R&D to Quality Control (QC): Developing QC-Friendly Analytical Methods

From R&D to Quality Control (QC): Developing…

Quality control is an integral part of the drug development…

Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective Drug Development

Phase-Appropriate Validation: How Tailored Approaches Support Cost-Effective…

Drug development is a complex and highly regulated process that…

Non-Clinical (animal) IND Enabling Studies: What You Need to Know

Non-Clinical (animal) IND Enabling Studies: What You…

In drug development, IND enabling studies serve as a vital…

Key Pharmacokinetic Factors in Topical Medication Development

Key Pharmacokinetic Factors in Topical Medication Development

Topical drug products are designed to deliver active ingredient on…

Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials

Clinical Manufacturing Explained: How CDMOs Support the…

The development of clinical trial material (CTM) is a critical…

NDA vs. ANDA: A Comprehensive Guide to Key Differences, Processes, and Regulatory Requirements

NDA vs. ANDA: A Comprehensive Guide to…

A New Drug Application (NDA) and an Abbreviated New Drug…

Stability Chambers: Testing Methods, Essential Equipment, and Applications

Stability Chambers: Testing Methods, Essential Equipment, and…

Stability chambers are a must-have in pharmaceutical research and development.…

Top 7 Questions for Small Pharma and Pharmaceutical Startups to Ask When Choosing the Right CDMO Partner

Top 7 Questions for Small Pharma and…

Most pharma companies use contract development and manufacturing organizations (CDMOs)…

Semi-Solid and Semi-Liquid Dosage Forms

Semi-Solid and Semi-Liquid Dosage Forms

Semi-solid and semi-liquid dosage forms are key pharmaceutical preparations that…

The Critical Role of Formulation Development in Product Success

The Critical Role of Formulation Development in…

All medicine administered to patients must first be formulated. It’s…

The FDA’s 505(b)(2) Explained

The FDA’s 505(b)(2) Explained

Pharmaceutical innovation can stem from a variety of different facets…

What is a CDMO and Why Does Your Company Need One?

What is a CDMO and Why Does…

What is a CDMO? A CDMO, also sometimes referred to…

Permeability Enhancers for Bioavailability Improvement

Permeability Enhancers for Bioavailability Improvement

A large number of promising compounds in the pharmaceutical pipelines…

Muco-Adhesion Testing

Muco-Adhesion Testing

Muco-Adhesion and Muco-adhesive Delivery Systems Muco-adhesion refers to the adhesion…

IVRT and IVPT: Pivotal Tools in Topical Product Development

IVRT and IVPT: Pivotal Tools in Topical…

Topical products are liquid or semi-solid dosage forms applied to…

Topical Dosage Forms: Product Development Overview

Topical Dosage Forms: Product Development Overview

Topical dosage forms are medications applied directly to the body…