Companies throughout the pharmaceutical industry touch the lives of patients around the world. Your pharmaceutical business needs to operate in conditions that are created to exceed cGMP expectations and industry standards — your products’ safety and superiority depend on it.
cGMP Consulting Services
If you’re expanding your operations or opening a new facility, the amount of equipment that needs to be validated may seem overwhelming. You need to ensure that your machinery, computer systems, utilities and the facility itself are all compliant. At Regulatory Compliance Associates® Inc., we can take this burden off your shoulders.
We offer more than 15 years of experience as a pharma cGMP validation service company, and we can handle your manufacturing and facility validation concerns. With our team of more than 500 leading industry experts and FDA veterans, pharmaceutical facility validation has become more accessible than ever.
Whether you are building a new facility or expansion to your existing operations; installing new capital equipment; re-validating existing equipment / utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate cGMP validation program to help.
As quality standards from regulatory agencies become more stringent, today’s pharmaceutical companies face increased challenges maintaining compliance with their facilities and processes. RCA is here to validate and re-validate your pharmaceutical equipment and facilities, helping you keep your operations running smoothly and provide the best care to your end users. We’ll perform an array of manufacturing support services, such as the following:
- We can assist with the entire validation life cycle continuum—starting with validation strategy/validation master plan through purchase, qualification, and commissioning
- We have cGMP experts that can help and guide you from design qualification, user requirement definition through factory/site acceptance and through commissioning and qualification. We have experts in: user requirement specification (URS), drug specification (DS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification/process qualification (IQ/OQ/PQ) summary reports
- Expertise in validation of: equipment, facilities, utilities, computer systems and controls supporting the areas of: manufacturing, laboratory, utilities, and processes
- Comparability protocols and re-validation of existing equipment and operations
- Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility
Deliver Exceptional Results With RCA’s Pharma Validation Services
As a pharmaceutical company, your end users’ safety is your top priority. Your products need to stay safe and effective, and nothing should get in the way of that reliability. Validation of your pharma company’s facilities is essential to ensuring your products’ safety and compliance with industry regulations.
RCA offers services that span the validation process. Along with validating your equipment, we’ll help you develop a strategy that begins with purchasing the best products and ends with continual compliance assurance and support. Our experts offer unique insight into the FDA and other regulatory bodies that we leverage to create the best manufacturing support services for your needs.
Small, local startups and Fortune 100 life science companies alike turn to RCA for our highly recognized services and support. We’ll help you find the best manufacturing solutions to maintain compliance — and if you’ve already received a warning letter, we have the know-how to successfully navigate the issue and regain compliance.
Bring a fresh perspective to your facility and manufacturing planning with RCA. We’re here to help you navigate the challenging world of pharmaceutical validation and support. For more information or to request a validation service, contact us today.