R. Donnelly & Associates - FDA Regulated Industries Consulting Services

R. Donnelly & Associates, Inc. (RDA) has been providing turnkey consulting services for FDA regulated industries since 1990. Our services have been provided to pharmaceutical, nutraceutical, food and medical device firms throughout the US and other countries. These services range from project management for facilities, process improvements, equipment commissioning and qualification, process validation, cleaning validation, regulatory affairs, and quality systems.

Our senior consultants have an average of 22 years of experience in the manufacturing of sterile, oral dosage and biological products.Therefore, we understand the manufacturing needs of cost-effective quality service providers.

Project Management

RDA will become your company's representative in managing projects. We use a quality system approach to achieve quality construction and coordination of all aspects of the project, with as little or as much involvement by the client as their staffing dictates.This approach includes:

• Grass roots and facility renovation - scope definition through first production runs
• Process improvements
• Technology transfer - between sites or companies
• Equipment specification, procurement and commisioning through production
• Validation services

Validation

RDA can either manage your whole project or provide individual consultants or technicians to meet your specific project's needs. Our services include:

• Validation master planning
• Design specifications
• User requirements
• Gap assessments
• Commissioning
• C&Q
• Equipment validation
• Process validation
• Cleaning validation
• Computer system validation

Regulatory Affairs

RDA can assist you in managing new product approvals through FDA responses. We cover:

• NDAs
• Device Submittals
• Audits: suppliers, manufacturing and quality systems

Quality Systems

Through proper use of quality systems, the whole manufacturing process comes under control. Personnel are properly trained, raw materials are received, manufacturing is coordinated, maintenance is timely, and warehouse and shipping are co-ordinated to work together, thereby minimizing reworks and delays, and providing a quality products manufacturing system that complies with FDA regulations.

TURNKEY PHARMACEUTICAL CONSULTING SERVICES

RDA strives to understand the client's needs and put together a plan to meet these needs. We can take on any project - from a new facility to a specific process problem - and provide the agreed results with as much or as little involvement from the client as the client has the resources for or deems necessary. We understand your problems and solve them.

cGMP COMPLIANT PRODUCTS

RDA's core mission is to provide clients across the globe with a professional product that is timely, cost-effective and compliant with all applicable FDA or other international regulations. We understand the FDA's approach to compliance, and we will create a new system or enhance an existing system in order to ensure that your product complys.

Our senior consultants have experience with FDA inspections and will present a balanced and defendable position that is cGMP compliant. RDA can prepare and execute validation protocols, operational SOPs and preventative maintenance programs, and we follow these up by training your staff in their execution.

RDA can assist your company in avoiding a 483 letter or, if you have already received one, we can quickly assist in remediation.

RDA's Mission

RDA's mission is to provide innovative, practical and top-quality services that save time. We aim to improve the way the industry handles FDA regulated issues through a team effort with the one goal of safe, effective and cost-effective products for our clients and their customers. Through a long term commitment to this mission, we are a company that meets and exceed our client's goals.