Why hire an experienced and knowledgeable FDA regulatory compliance specialist?
• Cost effective compliance to FDA regulations is best accomplished with a strategic approach. Regulations should be viewed as a set of guidelines, not as absolute statements of requirements. • If a firm simply follows the published regulations and guidelines to the letter without taking a creative posture, the firm’s compliance cost will be too high. • If a firm assigns in-house staff, with limited experience, to define the compliance strategy the potential cost of non-compliance can be staggering. • The best approach is to minimize the total cost of compliance by developing the optimal compliance strategy.
