What is Pharmaceutical Development?
Pharmaceutical development is a broad term used to describe the process of how a new or generic pharmaceutical product is approved for human or animal use. This is typically a long process with many regulatory stages. Pharmaceutical development requires a variety of chemical and biochemical tests to be performed, with all showing the new product is both safe and efficacious for its intended use.
Pharmaceutical Development at EKG Labs
The team at EKG Labs has years of experience providing services to help develop pharmaceutical products for a variety of therapeutic indications involving diverse chemistries. Our services help companies fully understand the chemical profile of their drug product as well any associated excipients, reference standards, and degradants. EKG Labs provides services that help companies answer questions like:
- How can I develop a stability-indicating method for my drug product?
- What are these degradants in my product and are they a concern?
- What type of methods do I need to support QC activities?
- How do I validate an analytical method and when do I need to do it?
Our pharmaceutical development services include:
- Extractables and Leachables
- Chemical Characterization
- Impurity Identification
- Method Development
- Method Validation
EKG Labs Pharmaceutical Development Therapeutic Expertise:
EKG Labs Pharmaceutical Development Dosage Form Expertise:
- Solid Oral
- Oral Suspensions