EMPQ Case Study: Carolina Components Group
Read this case study to learn how Alcami supported Carolina Components Group in the successful...
Read this case study to learn how Alcami supported Carolina Components Group in the successful...
According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...
Combination products are becoming increasingly important to pharmaceutical CDMOs like Alcami, said...
In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are...
Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...
Supporting a compound from discovery to clinical phases and potentially commercial phases requires...
The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that...
Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a...
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...
The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...
Given that serialization execution is new to many in the industry, what should drug developers look...
The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many...
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...