Analytical Method Development - Method Validation - Analytical Testing Laboratory
Method Development and Validation
Velesco's experienced analytical staff specializes in analytical method development and validation for early to late stage pharmaceuticals. We also have experience with OTC and neutraceutical products.
Velesco can become involved in your analytical CMC program at any stage. We develop drug substance and drug product methods from scratch, improve and expand existing methods, and even troubleshoot and fix problematic analytical methods. Our method validation will be appropriate for your situation and comply with ICH guidelines.
Our expert analytical chemists ensure that you will receive a robust, transferable, stability-indicating HPLC method that is tailored to your phase of development.
What is a stability-indicating method and why do you need it?
Phase of development is very important for efficient analytical method development and validation. Methods should be “fit for purpose”. Thus, methods for IND submission/phase I support are scientifically sound, but challenged in validation to a lesser extent than a phase III product method.
An early stage project usually does not have extensive analytical data. There are usually small, unknown impurities and unknown degradation profiles. During early development, large batch to batch changes in these impurity profiles can occur. Velesco’s analytical scientists are familiar with the challenge of extracting and separating the new components while minimizing changes to the method
Velesco takes a practical approach to analytical method development; we use solvents and columns that are affordable and readily available (unless a specialty item is necessary for the project).
Drug Product Release - Analytical Testing Laboratory
Our cGMP Kalamazoo, MI laboratory specializes in GMP drug product release and stability testing.
Velesco can also perform routine analysis, from simple melting point determination or UV/VIS scan to GMP Stability Testing. Submission Form.
Our Case Studies for Analytical Method Development challenges give a brief taste of the value our analytical services can bring to your project.
- Stability-indicating methods
- Drug substance
- Drug product (tablets, capsules, syrups, etc.)
- Forced degradation
- Chiral methods
- Stability testing in support of first-in-human studies
- Content uniformity method development, validation and testing
- Dissolution method development, validation and testing
- Blinded comparator agent testing
- Method troubleshooting
- Method optimization
- Reference standards
- Cleaning verification method development/validation
- Technology transfer