黄人导航

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance 黄人导航 team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.

 

Compliance Consulting Services

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA, we offer the pharmaceutical consultants & management consulting resources necessary to guide you in regulatory compliance.

 

We’re In Compliance

 

From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of FDA, MHRA, Health Canada and other regulatory agencies.

 

Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know.听

 

Regulatory Compliance Solutions

 

We offer the following pharmaceutical compliance services to keep our clients out of non-compliance:

 

Assessments听

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services include:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits听

 

Periodic regulatory audits are necessary to both ensure the continued compliance of your organization. An internal audit from a 3rd party business management consultant can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response听

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. RCA’s strategic consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness听

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option 鈥 you need comply with regulations and actively prepare. RCA听will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

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. Our pharmaceutical consulting Experts will create a customized approach depending on your product and 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. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, 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 goals. Regulatory Compliance 黄人导航 quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement 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, Remediation 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 RCA 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

 

Regulatory ComplianceRegulatory 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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