Methods Development

Methods Development Challenges

Methods development is defined as the creation, evolution, and validation of various procedures to ensure the safety and efficacy of a drug. Different phases of drug development require different criteria for testing, and the validation of those testing methods. Additionally, modification to the formulation of a product, the compliance considerations, the manufacturing requirements, and the dosing application can all necessitate new methods development.

As such, our pharmaceutical partners work diligently to establish the most effective, error-free methodologies possible. For the successful introduction and manufacturing of pharmaceuticals, we collaborate with global pharmaceutical companies on methods development, validation, and transfer.

Why Collaborate With EFC Pharma?

Methods development is a continuously evolving process that occurs throughout a product’s lifecycle, and is a critical component of compliance and quality assurance. A strategic CDMO collaboration can help companies successfully adapt and improve their methodologies as a new product advances through testing phases. EFC Pharma is adept at matching pharmaceutical companies with the right partner, putting product owners in a position to succeed when a drug product finally reaches the marketplace.

Methods Validation

This documented process ensures that a pharmaceutical test method is suitable for its intended use. To do this, a series of experiments is performed on the procedure, materials, and equipment that comprise the method being validated. The results undergo analysis, and a series of pre-defined acceptance criteria is applied to the results. A validated test method is one that has been proven to be accurate over a stated range and serves to establish the method robustness of the method. This is a required step in drug development and ensures the consistency and accuracy of the drug in question.

Methods Transfer

Once a method has been developed on site, it’s transferred to another site during the drug development process. This process of analytical method transfer is a regulatory requirement and is performed between two testing labs. This documented process verifies that a specific lab is capable of performing the analytical testing method’s intended use. This stage in the methods development process of a drug can significantly impact the launch of a product. That’s why working with a partner who understands the entire process and can effectively manage it through completion is critical.

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EFC Pharma proudly serves the pharmaceutical industry as the leading development, production, site transfer, and compliance specialists. Our relationships throughout the U.S and international markets allow us to facilitate the most profitable solution for your manufacturing and development obstacles. For further information about our production and development services, please contact us here.