by Cindy Delacour
Working with controlled substances poses its own challenges, of which Excite Pharma Services has worked diligently to not only stay in compliance with both the FDA and DEA, to ensure safe handling and traceability of controlled substance materials for all members of staff. Excite has a team of DEA authorized personnel who underwent background checks, drug screening, and follow all requirements and regulations as outlined in 21CFR Chapter II Parts 1300-1399.
Typically, when handling raw materials to be used in formulations for drug manufacturing there is a stringent process by which Excite Pharma Services adheres to from ordering, analysis, release, formulation, and throughout the manufacturing events and reconciliation. When it comes to controlled substances, these processes and documentation required are doubled. This attention to detail and due diligence is what brings clients to Excite Pharma Services for their drug manufacturing needs. Cindy Delacour is the Vice President of Quality Assurance, and it is her team’s responsibility to assure the company and its employees understand the intricacies of the regulations from the governing bodies.
With a focus on compliance Excite Pharma Services works vigorously to ensure their clients receive a high-quality finished product. There is no exception when working with Controlled Substances. Excite Pharma Services has an analytical lab and a manufacturing site that are registered to house and manufacture controlled substances (schedules 2-5). This level of quality and compliance brings clients peace of mind that their product is being safely handled and manufactured so that patients will receive a safe and efficacious effective product.
Although working with controlled substances pose differing levels of challenges Excite Pharma Services as a small size company has worked tirelessly to ensure that finished product(s) first and foremost abide by the company’s mission of Patient Safety for both Humans and Animals. It is this mission that is the driving force for Cindy and her team.
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