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®, 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
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.