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Blogs (2)

Understanding Pharmaceutical Packaging

For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are...

Blog: Stability’s Role in the Drug Formulation Process

From molecule discovery through product release to market, quality attributes are carefully...

Abuse-Deterrent Studies – An Interview with Angela Moore

As one of the key contributors to current abuse-deterrent studies being performed in the Alcami...

Stability Testing of Quality Attributes for Drug Products

The quality attributes that everyone strives for are safety, product efficacy and integrity,...

Part Two: Cell-Based Bioassays

Part Two: Cell-Based Bioassays

Part One: Biologics and the Problem with Residual DNA

Part One: Biologics and the Problem with Residual DNA

In-Use Stability Testing: Providing the Right Instructions

In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active...

What are Extractables and Leachables?

Regulatory agencies have become increasingly rigorous with regards to the detection, identification...

Execution and Reporting of a Photostability Study Protocol

The protocol design, execution, and reporting of the confirmatory photostability for API and...

Bringing the Light to Photostability in Three Parts

Part 1: Basic Requirements – Setting the Stage

Antibiotic Potency Testing: Diffusion (Cylinder-Plate) Method

Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of...

Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics

Several agencies within the U.S. Federal government are focused on reducing the prescription drug...

Blog: The Effect of Abuse-Deterrent Formulations on Opioid Abuse

In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse...