黄人导航

case study

Pharmaceutical Packaging

About RCA
Regulatory Compliance 黄人导航 Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Pharmaceutical Packaging

Client Size:

Global Medium Sized Company

Industry:

Pharmaceutical / Clinical Trials Supply

Project Timeline:

90 days + ad-hoc hours after submission

Business Challenge:

A Regulatory Compliance 黄人导航 client needed strategy and support with Pharma Licensing and Packaging & Labeling for a new greenfield facility.

 

Client Challenge

  • An existing pharmaceutical client specializing in clinical trials supply was looking to launch a new packaging facility. The manufacturing operations team needed support with development plans and regulatory compliance.
    • Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
      • Pharmaceutical packaging
      • Labelling in pharmacy
      • Pharmaceutical bottle
      • Packaging for tablets

RCA Approach

  • Scope of work included two staff augmentation resources to begin the project.听
    • The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
      • The Quality Specialist became a valued liaison while operating across departments inside the organization
        • Risk management tools were implemented in the following departments
          • Sterilization
          • Design Control
          • Validation
          • IT
          • Training employees.
    • The second resource was a Quality Subject Matter Expert with executive experience.
      • This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
        • All types of medicine packaging
          • Pharmaceutical packaging technology
            • Pharmaceutical filling
            • Pharmaceutical packaging solutions
          • Drug packaging types
            • Pharmaceutical primary packaging
            • Pharmaceutical secondary packaging
            • Pharmaceutical cold chain packaging
            • Plastic pharmaceutical packaging
          • Pharmaceutical labeling process
            • Pharma label
            • Pharma containers
            • Drug carton
            • Sustainable pharmaceutical packaging
          • Pharmaceutical packaging machinery
            • Blister packaging pharmacy
            • Unit dose packaging pharmacy

They also provide technical input and guidance from the perspective of many disciplines. After the implementation done by our Quality Specialist, this SME did the final validation of the plan and worked with the client on a 鈥渁s needed鈥 bases helping with any regulatory compliance issues.

Results

  • RCA’s Quality Specialist worked collaboratively with the clients鈥 teams to valitate all training and SOP development. Enhancements for the new packaging facility included.
    • Design Control team was trained extensively on risk management in packaging.
    • Technology team improved their manufacturing automation through functionality that recognized the difference between “Printed Text Error” and “Packaging Component” deviations.
      • This helped isolate the number of errors to a specific step in the package leaflet process.听
  • Assisted in identifying any gaps and/or opportunities with the firm鈥檚 plan.
    • Supported with any FDA authority enquiries and other global scenarios impacting the firm’s US Operations.
    • Implemented the secondary packaging and labelling protocols to match current licensing and marketing approval.

Conclusion

  • At the end of this project, the Quality Subject Matter Expert with executive experience delivered a comprehensive readiness check for the facility.
    • All the regulatory requirements
    • Inspection readiness recommendations
    • Process and production line validations
    • SOP documentation and training qualifications
  • The client was approved by both global regulatory bodies to successfully begin development of their new packaging facility.听

 

About RCA’s听Pharmaceutical Consulting Services

 

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

 

 

Client Size:

Global Medium Sized Company

Industry:

Pharmaceutical / Clinical Trials Supply

Project Timeline:

90 days + ad-hoc hours after submission

Business Challenge:

A Regulatory Compliance 黄人导航 client needed strategy and support with Pharma Licensing and Packaging & Labeling for a new greenfield facility.

 

Client Challenge

  • An existing pharmaceutical client specializing in clinical trials supply was looking to launch a new packaging facility. The manufacturing operations team needed support with development plans and regulatory compliance.
    • Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
      • Pharmaceutical packaging
      • Labelling in pharmacy
      • Pharmaceutical bottle
      • Packaging for tablets

RCA Approach

  • Scope of work included two staff augmentation resources to begin the project.听
    • The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
      • The Quality Specialist became a valued liaison while operating across departments inside the organization
        • Risk management tools were implemented in the following departments
          • Sterilization
          • Design Control
          • Validation
          • IT
          • Training employees.
    • The second resource was a Quality Subject Matter Expert with executive experience.
      • This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
        • All types of medicine packaging
          • Pharmaceutical packaging technology
            • Pharmaceutical filling
            • Pharmaceutical packaging solutions
          • Drug packaging types
            • Pharmaceutical primary packaging
            • Pharmaceutical secondary packaging
            • Pharmaceutical cold chain packaging
            • Plastic pharmaceutical packaging
          • Pharmaceutical labeling process
            • Pharma label
            • Pharma containers
            • Drug carton
            • Sustainable pharmaceutical packaging
          • Pharmaceutical packaging machinery
            • Blister packaging pharmacy
            • Unit dose packaging pharmacy

They also provide technical input and guidance from the perspective of many disciplines. After the implementation done by our Quality Specialist, this SME did the final validation of the plan and worked with the client on a 鈥渁s needed鈥 bases helping with any regulatory compliance issues.

Results

  • RCA’s Quality Specialist worked collaboratively with the clients鈥 teams to valitate all training and SOP development. Enhancements for the new packaging facility included.
    • Design Control team was trained extensively on risk management in packaging.
    • Technology team improved their manufacturing automation through functionality that recognized the difference between “Printed Text Error” and “Packaging Component” deviations.
      • This helped isolate the number of errors to a specific step in the package leaflet process.听
  • Assisted in identifying any gaps and/or opportunities with the firm鈥檚 plan.
    • Supported with any FDA authority enquiries and other global scenarios impacting the firm’s US Operations.
    • Implemented the secondary packaging and labelling protocols to match current licensing and marketing approval.

Conclusion

  • At the end of this project, the Quality Subject Matter Expert with executive experience delivered a comprehensive readiness check for the facility.
    • All the regulatory requirements
    • Inspection readiness recommendations
    • Process and production line validations
    • SOP documentation and training qualifications
  • The client was approved by both global regulatory bodies to successfully begin development of their new packaging facility.听

 

About RCA’s听Pharmaceutical Consulting Services

 

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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