黄人导航

Assessments

Regulatory Compliance 黄人导航 knows how quality or compliance crises can significantly impact your business鈥攁nd we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and compliance assessment solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment.

 

While not an all-inclusive list, our Compliance Assurance Assessment services for the Pharmaceutical industry include:

 

  • Current Good Manufacturing Practice (cGMP)
  • International Organization for Standardization (ISO)
  • Quality Infrastructure
  • Corrective and preventive Action (CAPA)
  • Validation
  • Facility and Maintenance
  • Pre-Approval Inspection (PAI)
  • Data Integrity
  • Start-up Assessments

 

Pharmaceutical Mergers & Acquisition / Due Diligence

 

When a life science company considers a merger or acquisition, it is easy to think of the deal’s risk as a potential conflict with the FDA or its equivalent in other countries. The due diligence team looks for 483s, Warning Letters, notified bodies and findings, and product recalls. But more often, the real reasons a deal doesn’t deliver value are strategic, cultural, or technical. It’s these value-destroying areas that need to be explored during due diligence. We can help a company make the right decision.

We leverage our global experience with acquisitions and divestitures to navigate the gray areas of due diligence and help eliminate uncertainties often inherent in a complex deal. These include:

 

  • Regulatory Due Diligence
  • Quality Due Diligence
  • Facility / Equipment Assessment
  • Personnel Assessment
  • Risk Identification and Mitigation Planning
  • Post-merger Integration
  • Compliance Assessment

 

Additional services related to assessments include:

  • 21 CFR Part 11 / Annex 11 Assessment
  • 21 CFR Part 210 and 211 Assessment
  • Good Laboratory Practice (GLP)

 

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 customized 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 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, 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, 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 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

 

pharmaceutical consultantsRegulatory 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, we can negotiate the potential minefield of regulatory compliance and regulatory听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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