Our experience brings knowledgeable and cost-effective services to your company.
R. Donnelly & Associates, Inc. has more than 25 years of experience in FDA regulated industries. Ralph Donnelly, President and CEO, has put together a team that has the experience and initiative to provide practical, effective and timely solutions for our clients’ needs. Whether your needs are for compliance, regulation, quality, production or engineering, RDA can provide consultants that will listen, understand and provide solutions that are targeted to your specific circumstances.
RDA is committed to providing FDA regulated industries with hands-on consulting services. Our consultants have experience in OTC, sterile products, medical devices, dietary supplements and compounding pharmacies. We have provided proactive cGMP audits, FDA remediation, process improvements, validation, and facility design through operations project management. We have also assisted start-up companies in developing their quality systems and helped companies set up and manage their technical services department from employee selection and training through validation.
Our lead consultants have operations experience. Whether you manufacture pharmaceuticals, biological products, medical devices, dietary supplements or are a compounding pharmacy, our consultants will take the time to understand your real needs. We understand that all companies are not alike and that the solutions to problems may be different from client to client. We listen to our clients and tailor our efforts to meet your specific needs.
Our consultants have experience with proactive FDA compliance, FDA remediation, validation services, and facility project management. We pride ourselves in providing cost-effective value-added results. In every service RDA provides, we are committed to helping our clients succeed in achieving their goals and objectives.
Pharmaceutical, medical device, biotechnology and hospital pharmacies
RDA will coordinate the planning, developing of optimum contracting method, managing design, construction, commissioning and validation.
RDA will assist in auditing and developing a Quality System that will optimize compliance and operations. Engineering solutions will be evaluated and integrated into the Quality Systems to build quality into your processes and products.
Violations and/or inadequate procedures require swift and appropriate remediation. When an audit results in an FDA 483 / Warning Letter, RDA assists in corrective action. Remediation is designed for each client to ensure quality and timely compliance. RDA provides leadership in compliance remediation and training for sustainable compliance.