黄人导航

Quality Assurance

Regulatory Compliance 黄人导航 Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous QA improvement, aligning with your QA engineering team and business needs.

 

Quality Consultant Services

 

Quality is something our Expert quality assurance consultants have that spans both major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this quality assurance knowledge to your quality engineering team.

 

QA Services

 

  • Quality Assurance Consultants 鈥 Interim Management, staff augmentation, or outsourcing quality and regulatory management has become increasingly common in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies. Quality assurance and testing needs may vary greatly depending on the organization’s lifecycle, and RCA’s quality consultants are up to the task.听
  • QA Audit 鈥 Virtual gap assessments can assist your team in advance for an upcoming QA inspection by a notified body. These proactive organizations turn to RCA for quality assurance consultant Experts who can describe the highest quality standards a notified body will look for.
  • Quality Assurance in Software Testing 鈥 Cybersecurity is becoming more essential to our industry based on updated FDA cybersecurity guidance. Pharmaceutical manufacturers partner with RCA for their cybersecurity FDA strategy and how to stay ahead of hackers.听

 

QA Process

 

Early in a company’s lifecycle, strategic leadership is needed for鈥 鈥媝roduct filings, regulatory pathways, manufacturing setup, and quality management systems creation. As the company matures, QA planning often transitions to a QA consultant who can support the continuous improvement stage to leverage quality assurance services that support the quality control manager & department.

 

  • Total Quality Assurance
    • Quality Assurance Methodologies
    • QA Procedures
    • Project QA
    • Product QA
    • Supplier QA
    • Digital QA
    • Agile QA

 

Outsourcing QA can often provide needed quality control in management when you’re challenged with a lack of bandwidth. RCA can provide quality assurance process monitoring to help measure the impact of process changes & quality control improvements across your engineering teams. The pharmaceutical quality experts of Regulatory Compliance 黄人导航bring a wealth of quality assurance management needed to help you cut cost via unique QA methodologies.

 

QA Planning

 

Hope is not a strategy when the FDA auditor knocks on your door to begin a quality assurance inspection. Our QA inspection Experts can help you prepare your front room and back room strategy in advance for the best scenario with any quality assurance auditor. RCA’s proven quality assurance methodologies are based on a deep expertise of quality assurance in healthcare and how to develop a quality assurance plan your QA auditor will accept.听

 

  • Quality Control Audit
    • QA Procedures
    • QA Reporting
    • QA Responsibility
    • SOP Quality Control
  • QA Best Practices
    • QA Programmer
    • QA Project Manager
    • QA Software Tester
    • SQA Tester
    • Software QA Analyst
    • Software Quality Analyst
  • Quality Assurance Training
    • Standard Quality Control
    • Quality Control Tester
    • Quality Assurance Analyst
    • Data Quality Analyst

Software QA

 

  • Software QA Outsourcing
    • Agile Quality Management
    • Web Quality Assurance
  • Software Quality Control
    • Quality System Automation Using Software
    • Quality Systems Implementation
    • Quality System Remediation / Improvement
  • Quality Control Procedures
    • Computerized System Validation Standard Operating Procedure (SOP) 鈥 Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model. RCA’s healthcare consulting Experts can ensure that you have the appropriate level of documentation.
    • Risk Management ICH Q9 鈥 RCA’s business management consultant team can provide you with the tools needed to implement or remediate your quality systems. Every RCA quality technical consultant understands current industry standards and how to train your personnel.

 

QA Teams

 

  • Corrective and Preventive Action (CAPA) and Complaint Systems 鈥 We manage the implementation and remediation of CAPA systems and Complaint Handling Systems.
  • 21 CFR Part 210 and 211
  • Quality Control Assurance
    • EU Good Manufacturing Practice (GMP)
    • Quality Assurance Best Practices
  • QA Testing Process
    • Performing Quality Control
    • QA Workflow
  • Quality Culture Guidelines
    • QA process
    • QA Tester
    • QA Analyst
    • QA Management
  • Laboratory Support
    • SOP Development
    • Method Transfer
    • Method Validation
    • Data QA

 

About RCA’s听Pharmaceutical Consulting Services听

 

Regulatory Compliance 黄人导航 (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance 黄人导航 offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance 黄人导航 team knows the unique inner workings of the regulatory process.听

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance 黄人导航 will guide you through every pharmaceutical consulting step of the regulatory process and create a customzed approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance 黄人导航 backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance 黄人导航, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance 黄人导航 Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and what quality assurance means to your quality assurance manager.

 

Our quality assurance services include Q&A testing experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

Remediation Services

 

Regulatory Compliance 黄人导航 has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance 黄人导航 pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance 黄人导航 pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance 黄人导航

 

quality assuranceRegulatory Compliance 黄人导航听(RCA) provides pharmaceutical consulting to the following industries for resolution of life science 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 , , and globally-regulated companies.

 

As your partners, Regulatory Compliance 黄人导航 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鈥檚 unwavering commitment to its mission, Safeguarding Global Health.

 

Sotera Health Company, along with its three best-in-class businesses 鈥 ,听听and听, 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听

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