The USA Food and Drug Administration (FDA) recently provided updated regulatory guidance for Product Lifecycle Management in the pharmaceutical industry. The guidance helps pharmaceutical companies and manufacturers better understand the administration of post-approval chemistry, manufacturing, and controls changes.

 

Lifecycle Management

 

The guidance provides new insights into lifecycle management concepts for both new and existing pharmaceutical products, including chemical and biologics. The FDA regulatory team looked to synchronize its updated guidance more closely to ICH guidelines used with other global regulatory agencies.

 

The benefit realized by pharmaceutical companies would be options for reducing duplicate clinical studies and increasing the standardization of safety information reporting. By revising facets of FDA marketing application submissions as well, the Agency appears to be taking a more holistic approach to improving drug development quality and pharmaceutical manufacturing strategy.

 


Looking for help Managing your product’s Life Cycle? Talk to our Experts →


 

Manufacturing Process

 

Changes include language revisions to surrounding regional legal frameworks, an expanded clarification of critical process parameters, and identifying established conditions for manufacturing processes. One important revision for regulatory affairs employees is the new recommended content of the product lifecycle management document and its location within the technical file. Clarity revisions were also made to further expand on the use of available tools described in the guideline for master files.

 

Regulatory Submission

 

The new FDA guidance also expanded its language on post-approval chemistry, manufacturing, and controls changes. With additional tools and principles intended to improve the industry’s management of post-approval changes, FDA leadership is hoping to increase transparency between both industry employees and regulatory authorities.

 

The benefit to pharmaceutical companies should be a deeper understanding of how product and process knowledge will contribute in the real world to post-approval changes that require a regulatory submission. By defining the level of reporting categories, industry experts should experience a deeper understanding of risk compared to product quality.

 

Quality Management System

 

The new tools and principles are designed to improve data input into a company’s quality system. The goal is to enhance the industry’s ability to manage many chemistry, manufacturing, and controls changes that have a lower priority needed of regulatory oversight.

 

At the same time, many at the FDA are hopeful the tools and principles could result in fewer Marketing Authorization Application submissions that increase the associated regulatory burden. The guidance should increase both operational efficiency and regulatory flexibility when implemented with the proper regulatory framework and applied with widely accepted risk management principles in the pharmaceutical industry.

 

Pharmaceutical Consultant & Pharma Consulting Services 

product lifecycleRegulatory Compliance Associates® (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 Associates® 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 industry executives of the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates® team knows the unique inner workings of the regulatory process. 

 

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 Associates® will guide you through every pharma consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 Associates® 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

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 Associates®, 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

 

Quality Assurance

Regulatory Compliance Associates® 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 Associates® pharmaceutical industry consultant are 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

 

Remediation 

Regulatory Compliance Associates® has significant experience and a proven 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, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. Regulatory Compliance Associates® pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.

In addition, Regulatory Compliance Associates® pharmaceutical industry consultant will prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

product lifecycleRegulatory Compliance Associates® (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 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®.

product lifecycleSotera 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. 

 

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have recently identified 10 guiding principles for the development of Good Machine Learning Practice (GMLP).

 

These guiding software development principles should be used to:

 

  • Adopt good practices that have been proven in other sectors
  • Tailor practices from other sectors so they are applicable to medical technology and the health care sector
  • Create new practices specific for medical technology and the health care sector

 


Need help putting these principles into action? Talk to our Experts →


 

What is Artificial intelligence and FDA machine learning (AI/ML)?

Artificial intelligence and machine learning use software algorithms to learn from real-world use of the device to help improve the product’s performance.

 

Good Machine Learning Practice Guiding Principles

 

  1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Lifecycle. Helps ensure that ML-enabled medical devices are safe and effective and address clinically meaningful needs over the lifecycle of the device.
  2. Good Software Engineering and Security Practices Are Implemented. Implementation with attention to the “fundamentals”: good software engineering practices, data quality assurance, data management, and robust cybersecurity practices.
  3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population. Manage bias, promote appropriate and generalizable performance across the intended patient population, assess usability, and identify circumstances where the model may underperform.
  4. Training Data Sets Are Independent of Test Sets. Training and test datasets are selected and maintained to be appropriately independent of one another.
  5. Selected Reference Datasets Are Based Upon Best Available Methods. Using the best available methods for developing a reference dataset ensures that clinically relevant and well-characterized data is collected and the limitations of the reference are understood.
  6. Design Is Tailored to the Available Data and Reflects the Intended Use of the Device. Design is suited to the available data and supports the active mitigation of known risks, like overfitting, performance degradation, and security risks.
  7. Focus Is Placed on the Performance of the Human-AI Team. Human factors considerations and human interpretability are addressed with emphasis on the performance of the Human-AI team.
  8. Testing Demonstrates Device Performance during Clinically Relevant Conditions. Developed and executed statistically sound test plans to generate clinically relevant device performance information independently of the training data set.
  9. Users Are Provided Clear, Essential Information. Users are provided ready access to clear, contextually relevant information that is appropriate for the intended audience.
  10. Deployed Models Are Monitored for Performance and Re-training Risks are Managed. Models have the capability to be monitored in “real world” use with a focus on maintained or improved safety and performance, as well as periodic training after deployment.

 

About RCA’s Medical Device Consultants

 

fda machine learningThe regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business.

 

RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. 

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

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, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

 

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA

 

medical device consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for 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 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

 

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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