Chemical Development and API Manufacturing
We offer customer-based consulting services in the areas of API manufacturing. Our team of experienced and knowledgeable team will review your API program and suggest manufacturing plan.
FDA registration and marketing
We will register overseas manufactures to market and sell their drug products in united states. This will be based on the company portfolio and will be discussed on case by case basis.
Process Validation strategy
We offer strategy for your API process validation. We will manage your CMC activities based on your project and phase appropriateness.
Computer systems validation and Compliance
The U.S. Food and Drug Administration (FDA) and other international agencies require that computer software infrastructure and applications are appropriately tested for their regulated uses. Validation provides the required documented evidence through a process of planning, requirements definition, test development, test execution and final reporting. Additionally, operational procedures are reviewed to ensure ongoing compliance. We are specializes in providing full scope validation and compliance services to ensure that mission critical business systems are functional and in compliance.