21 CFR Part 210 and 211

Maintaining compliance to 21 CFR Part 210 and 211 is critical to the pharmaceutical industry. This includes adherence to current good manufacturing practice (cGMP) by understanding and implementing the processes and procedures defined in FDA Guidelines.


Companies that require assistance in establishing, maintaining, or improving their quality systems and procedures because of compliance violations can get professional, reliable, and actionable strategies from Regulatory Compliance Associates and our network of experienced 21 CFR Part 210 and 211 consultants. 


We can assist with answering 483 observations and developing long-term strategies that will help your organization maintain compliance through continuous process and system improvements. Impact analysis and risk assessment activities can include but are not limited to:


  • Review and Improvement of Investigations/CAPAs
  • Development of Training Modules for Comprehension to Various Parts of the Regulations
  • Strategic Review and Assessment of the Organization for Personnel Optimization
  • Redesign and Improvement of Laboratory Operations
  • Method Transfers and Instrument Qualifications
  • Process Validations, Technology transfers
  • Review and Assessment of the Effectiveness of the Internal Audit Function
  • In-depth System Audits and Recommendations for Improvements
  • Site Inspection Readiness Activities and Mock Inspections
  • Review and Assessment of Complaints
  • Supplier Quality Programs and Quality Agreements


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA®) provides healthcare consulting services to the following industries for the 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 Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 


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