CFRA Associates 

Product Development Consultation

Developing safe and effective products that meet regulatory requirements is crucial for success in the life sciences industry. CFRA Associates offers product development services to support clients in bringing their innovative ideas to market. Our team of experts provides regulatory guidance, quality system implementation, and validation support throughout the product development process, ensuring compliance with applicable regulations and industry best practices.

• We will assist in the planning, and execution of new product development from the concept to commercialization of the drugs, biologicals, and medical devices. 

• Medical device development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MDR compliance like device discovery, risk analysis,  concept, feasibility, design development, prototype, verification & validation, final validation, and product launch preparation.  

• Drugs and biological development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MAA compliance like Formulation development, pre-clinical and clinical studies design development, product approval strategy, and product launch preparation.