Brian Matye, CEO
The companies in the pharmaceutical industry are under constant pressure to adhere to the changing compliance and regulatory policies. To stay efficient amidst the tight regulatory conditions, the drug manufacturers should accurately interpret the legislation and implement every demanded change in a well coordinated and cost effective manner. The Pleasant Prairie, WI based firm, Regulatory Compliance Associates (RCA) provides full range of solutions to aid pharmaceutical enterprises meet compliance and regulatory obligations. “With RCA, clients know that our experts are uniquely situated to not only understand the issues, but can also readily help them navigate the challenges of compliance, regulations and sustainability,” says Brian Matye, CEO, RCA.
The firm offers risk management to facilitate good decision-making with regards to risk identification, resource prioritization, and risk mitigation or elimination as appropriate. The company’s effective quality risk management approach further ensures high quality of drug products to the consumers by providing proactive means to identify and control quality issues during development and manufacturing. This service also includes systematic processes designing to coordinate, facilitate and improve science-based decision making with respect to risk. Through effective process validation, RCA enable pharmaceutical enterprises to assure drug quality by collecting and evaluating data from the process design stage to the commercial production stage thereby, establishing scientific evidence to the quality standards of production process.
RCA offers assessment of individual risks related to specific products and starting materials, enabling drug manufacturers to recognize various hazards at specific stages of production or distribution. The service helps manufacturers to comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Implementing GMP ensures that the pharmaceutical products are produced and controlled as per the quality standards and achieve pharmaceutical compliance.
For the effective implementation and practice of the risk management principles RCA provides effective training to the enterprises also assisting them during inspections
GDP on the other hand make sure that medicines are obtained from licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by product specification. The assessment process also helps enterprises to identify all the risks that may be reasonably expected to occur in the activity under evaluation and their consequences. Additionally, the company offers comprehensive audit services to help organizations ensure safety through monitoring contract manufacturers.
For the effective implementation and practice of the risk management principles RCA provides effective training to the enterprises while assisting them during inspections. Many customer success stories stand as a testament to the company’s expertise in eliminating complexities that prevail in the pharmaceutical compliance domain. In one instance, a pharmaceutical-grade bulk chemical manufacturer had to execute gap analysis across 8 quality and 29 laboratory software systems for compliance. RCA by partnering with the client to solve the issue developed an assessment strategy including client interviews for each software systems and risk evaluation to determine the highest risk software systems based on compliance. Based on this, the software system was prioritized to create a remediation plan to bring all solutions into compliance. The customer was well qualified as a complying enterprise during the food and drug administration audits.
Moving forward, RCA plans to continually update and expand their expertise in the pharmaceutical compliance arena to help organizations to alleviate the pressure of frequent scrutiny by regulators, and responding by developing sustainable compliance strategies.