Chemical Analysis During Drug Development
Developing a new, potentially life-saving drug is a time consuming and financially intensive endeavor. There is simply no room to miss something along the way. Avomeen provides full support to biopharmaceutical companies throughout the drug development process to ensure regulatory standards and requirements are met.
When you’re developing a drug, we’re with you every step of the way. Learn how we stand by your side during each phase of the development process.
During the discovery phase, we offer characterization, method development, and method qualification assistance.
Through dose verification and continuing method qualification, we help you get your product ready for clinical trials.
During the clinical trials phase, we measure clinical stability, test raw materials, offer facilities and process validation, and perform method validation.
Review, Approval & Post-Approval
Our services support your development through the provision of scientifically sound data to verify safety, effectiveness, and controls.
Our full support program is designed to see your drug development from inception to the post-approval phase. Benefit from the assistance we provide to meet the many regulatory requirements imposed on drug manufacturers throughout the approval lifecycle.
Why Your Company Needs a Full Support Program
Our chemical testing laboratory offers full-service product testing and is cGMP compliant. Avomeen’s full support program combines the expertise of our six departments to bolster your product’s integrity both pre- and post-approval. Some of the benefits you can expect from our full support program include:
- Chemical analysis. In the discovery phase of development, we can help identify materials and quantify the API and excipients present in a product.
- Failure and liability testing. We can identify the cause and develop a solution to product failures prior to initiating the approval process.
- Start-to-finish guidance and support. We help your brand meet stringent regulatory requirements throughout the product development cycle so that you are compliant with federal laws and guidelines while retaining intellectual property integrity.
- Litigation support. If needed, we provide Ph.D.-level experts with decades of investigational analytical experience that can speak to the intricacies of product development, failure, trade secret violations, product liability cases, and more.
Areas of expertise include product evaluation and certification, product defect and failure analysis, product stability and release testing, and custom synthesis.
Get Support You Can Trust
A lot can go wrong when bringing a new product to market, including roadblocks that halt drug development. Our full program support gives your biopharmaceuticals the best possible chance of approval and market entry.