Click to watch Regulatory Compliance Associates medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing user needs & translating design benefits into long-term patient efficacy.

 

 

Developing an original product idea is difficult but many common tools & processes are consistently used. The early stages of product development include analyzing user needs and how those translate into design inputs.

 

Product Development Strategy

 

Ideation and product development life cycle research can help you identify user needs. Additionally, increasing the quality of an existing product is often a successful new product development strategy. Your solution doesn’t have to be a radically new idea.

 

Does it have a substitute product that can take market share? Or, can you combine the features of multiple products during the product design process to make a combination product that patients prefer more? Could a product design consultant help answer these questions & provide knowledge transfer?

 

Product Development Cycle

 

Start by asking your cross-functional team an initial question: “What do we need to change to achieve success during the product development cycle?”. Product development strategy includes modifying existing systems & processes to accelerate efficiency. Refine your model or process based on the unique types of product solutions in your pipeline.

 

Product Research

 

Being able to understand & explain why your solution addresses a user needs statement is inherent to launch sales success.  Interactive activities can be useful for improving creative conversation during market development strategy sessions. Further, voice of the customer (VOC) research consistently helps target the patient population in mind. 

 

Finally, using VOC to identify early adopter audiences & the audience’s most important needs can increase early interest in your solution. Begin the sales process by determining core messaging ahead of the launch ramp-up based on device claims & if the regulatory submission is approved.

 

Market Development Strategy

 

User needs are the foundation of any successful market development strategy. Yet, being able to commercialize a new solution based on user needs using a team experiencing process problems is never an easy task. It requires the Engineering Team & Operations Team at the listening table earlier in the process than later. 

 

Product Design and Development

 

A critical to quality objective early in the new product development process is removing everything but the essentials. Research your users needs to create design inputs for a product that patients both need & generates revenue.

 

Product Planning Process

 

After a business case is determined in the waterfall method, the product planning process begins cross functionally to validate product ideas via new product development research. What user needs will accelerate a successful product launch the fastest?

 

Innovative product design means addressing honest opinions from your target audience to validate your medical device solves a problem. The product development management team must be convinced the product can win in the commercial marketplace sooner rather than later.

 

Software Product Design

 

Success during the launch of a software as a medical device is often found at the heart of the product development plan. Any new product design must incorporate value added for the audience in one way, shape or form. This can include lean product design as some of the most effective software in the industry is not complicated.

 

Software as a Medical Device

 

Consider the regulatory differences between a tangible product and a technology product very carefully. For example, Software as a Medical Device (SaMD) has changed the marketplace by increasing both clinical research success & primary care delivery. Include process improvement sessions during internal meetings where a collective group deciphers what the user need statements mean to their team. 

 

Agile Product Development

 

The vision for development begins with a minimum viable product, or MVP, during early software conceptualization & development; what is the business case of commercialization? How do we learn faster while making real time efficiency changes?  

 

Digital Product Development

 

Product development teams must answer several questions before undertaking product design. Further, one focal ask is are successful processes already in place for medical product development.

 

Do you have a RACI chart to show who is responsible, accountable, considered, and informed? Finally, a clear cross-functional understanding of timelines & milestones can help guide expectations during MVP product development, which can be stressful based on the speed of common work.

 

MVP Agile

 

MVP (Minimum Viable Product) a widely accepted concept in software development in digital product development. However, our medical product design discussion will take a different direction – what is the regulatory affairs process?

 

A project management software development team should deliver a safe, efficacious solution with the objective of delivering patient value. Define your value through a regulatory strategy based on device claims, clinical evidence, and how both help the patient population.

 

Regulatory Compliance

 

Software as a medical device involves regulatory compliance based on multiple, widely accepted global standards.

 

  • This includes:
    • ISO 13485
    • IEC 62304
    • IEC 62366
    • ISO 14791

 

The product development engineering team is responsible for the software process. Any prototype development assistance should begin with a regulatory compliance perspective of claims and predicate devices.

 

Prototype predicate concepts begin with identifying the current risk class & why use cases help validate your proposed risk class during regulatory submission. Finally, consider younger product developers who may have never been through regulatory approval in their career. FDA readiness training can be a powerful tool that increases marketing approval & how to carefully identify and isolate risk hazards.

 

Regulatory Pathway 

 

Planning the build for a product requires a regulatory pathway that includes risk management considerations based on the risk class. Create as much detail as possible during this prototyping and design inputs phase of NPD.

 

Product development companies, like Regulatory Compliance Associates, can help identify the correct predicate device based on a risk gap analysis.  Diagrams should include material ingredients that need to be sourced to create the product. This can help you determine the risk category of the product (e.g. patient daily use, HCP specialty use, etc.) and corresponding patient hazards.

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides life science consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

 

Life Science consultants

 

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. Our life science consultants 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
  • 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®.

 

sotera healthSotera 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.

 

Regulatory Compliance Associates Medical Device Consulting Services

 

The 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 life science consultants — 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. We offer expertise in a variety of medical fields, such

 

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®, 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® ‘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, Health Canada & MHRA 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®‘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 life science 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 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are 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® 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® life science consultants 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 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

 

Regulatory Compliance Associates Pharmaceutical Consulting Services

 

Regulatory 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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® will guide you through every 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 four 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, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

 

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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants 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.

 

  • 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. We 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.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA® can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

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

 

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 FDA recently updated guidance for clinical trials & trial design (2022). This update stems from an objective of the 21st Century Cures Act (Cures Act). It includes recommendations for how industry sponsors of pharmaceuticals or biologics should design and conduct clinical trials. The guidance provides a greater explanation of how biologic and oncology trial design can simultaneously evaluate more than one investigational drug.

 

FDA Guidance

 

The guidance goes into depth about the clinical research milestones of master protocol design. Data integrity considerations are also mentioned for biomarker co-development and trial statistical analysis. Traditionally, oncology clinical trials are designed to assess multiple investigational drugs at the same time. Clinical data in this type of design is analyzed across multiple cancer types during the same trial to find all sources of patient efficacy and commercial value.

 

Another primary driver is the CDMO race due to testing multiple drugs and sub-populations under the same protocol. Pharmaceutical consultants like RCA Inc. have witnessed a shortening of client commercialization timelines across the life sciences industry. This directly adds incremental pressure on project sponsors. Clinical teams are being tasked to discover late-stage drug success faster than ever before. Every trial must simultaneously ensure patient safety while producing data that satisfies the regulatory safety and effectiveness.

 


Need help with your Clinical Trials? Talk to our Experts


 

Investigational Drugs (IND FDA)

 

The FDA concisely describes this unique protocol design and clinical trial planning for IND filings and multiple sub-studies. Sub-studies may have separate goals and require aligned efforts across the data science team. For example, collaboration is needed in order to appropriately value multiple investigational drugs. Consideration should be given that therapeutic value may be in one or more disease sub-types in the clinical trial.

 

With these considerations in mind, the FDA goes on to describe the benefits of a master protocol across the study design. This provides the project sponsor design flexibility via electronic data capture (EDC) in an EDC system (e.g. shared control arm, adaptive designs, centralized data capture).

 

Clinical Trial Design

 

This new FDA guidance also provides insights on potential challenges the industry should consider when using master protocols. These unintended consequences can include greater difficulty when assigning detailed adverse events to an investigational drug if numerous products are being investigated across the clinical study.

 

Any lack of adverse event reporting clarity can impact the safety profile of an investigational drug. This directly makes the clinical analysis for FDA approval more complicated for the regulatory body. Multiple study groups can also increase the overinterpretation of study findings. For example, signs of positive product efficacy for cardiac biomarkers could be different than from cancer biomarkers. Biomarker discovery for one subpopulation could also be identified as false if based a different ad hoc patient group.

 

Basket Trials

 

Basket trial design includes assessing an investigational drug blend by including a dose-finding or safety lead-in component. The goal is to identify safe quantities of the combination early in the clinical trial before progressing with an efficacy activity-estimating factor. The FDA proposes therapeutic efficacy for sub-studies within basket trials are constructed as single-arm, activity-estimating trial. The primary endpoint would be recorded as total response rate.

 

The guidance goes on to elaborate on sub-study objectives, including study rationale for each population. A comprehensive statistical analysis plan (SAP) with reasoning for sample size and unique stopping rules based on ineffectuality should also be included in the program documentation.

 

Umbrella Trials

 

A master protocol designed to evaluate multiple drugs is commonly referred to as an umbrella trial. These umbrella trials are often administered as a single drug or as a combination product. Umbrella trials are often a randomized controlled trial to evaluate the mechanism of action of the investigational drug/drugs with a common control arm. Study design for an umbrella trial can include sub-studies based on a patient biomarker or to a separate therapeutic sub-study inside the trial.

 

Clinical Study Design

 

As the clinical study focus, the FDA provides a clear understanding of how project sponsors improve the efficiency of master protocols. For example, using a common control arm during an Umbrella Trial has proven to help evaluate multiple drugs simultaneously for a single disease state.

 

Control Arm

 

For clinical trials, the FDA now recommends a project sponsor use a common control arm when numerous drugs are evaluated simultaneously in a single illness (e.g. umbrella trials). The FDA guidance elaborates in the use of a control arm be the current standard of care (SOC) so trial results are understandable from the perspective of the biologic and oncology medical community.

 

Changes in SOC can also take place during the trial because of an FDA approval or the latest scientific data. The Statistical Analysis Plan (SAP) would need to be revised before any data analysis occurs if this is the case.

 

Novel Drugs

 

When a project sponsor uses sub-studies to assess two or more investigational drugs, the FDA advocates for providing a thorough scientific motivation for the combination. This includes the clinical trial sponsor defining the Recommended Phase 2 Dose (RP2D). Analysis should include each novel drug and ensuring the appropriate dosage has been identified for each individual drug.

 

Targeting Biomarkers

 

The FDA goes on to elaborate on digital biomarkers to help validate the patient selection and recruiting for clinical trials. Biomarkers should be clearly identified based on the intended therapeutic response.

 

For example, an oncology biomarker for tumor size can help predict the response to the investigational drug. This type of study biomarker might demonstrate how the mechanism of action succeeded or failed. There needs to be a consensus among the clinical study team on how biomarkers are justified. Understanding study measures for showing marker positivity before patients enter the trial is critical.

 

Data Monitoring

 

One final important note about the master protocol in the updated FDA guidance describes the independent radiologic review committee. This committee medical research should include blinded tumor-based assessments to provide a charter for the independent data monitoring committee (IDMC).

 

The IDMC charter would guide the committee through ad hoc trials, such as patient efficacy and drug futility. The IDMC can also recommend clinical trial protocol actions. This often includes changes in sample size or modification of a sub-study based on overwhelming futility or efficacy evidence.

 

About RCA

 

Regulatory Compliance Associates® Inc. (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. Our team possesses 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. 

 

 

fda guidanceThe pharmaceutical and biologics industry recently received updated FDA guidance on the use of Generally Accepted Scientific Knowledge (GASK) in regulatory submissions.

 

The FDA guidance provides new examples of when it is applicable to leverage GASK data to meet safety requirements required in a new drug application. Clinical information in the drug discovery data that supports the nonclinical safety of a drug can contain GASK citations. Additionally, the citations would be based on existing clinical studies that have been validated by FDA in approved products on the market.

 

What is GASK?

 

Generally Accepted Scientific Knowledge refers to information and methods widely considered as accepted by life science industry experts. It can include established scientific principles, published papers, and best practices that have passed the regulatory scrutiny of drug development. GASK is most often utilized during the evaluation of safety and efficacy data of regulated products.

 

FDA Approval

 

The FDA guidance elaborates on the process of FDA regulators and how new drug applications are evaluated. Further, the FDA often requires life science companies to provide a significant amount of regulatory data to support safety and efficacy claims.

 

This regulatory clinical research often comes from clinical trials, preclinical studies, and other types of scientific data sources. However, in scenarios where there may be limited clinical trial data conducted, GASK can be used to provide supporting documentation for regulatory compliance. 

 

Drug Development

 

Life science companies are required to offer nonclinical information to support regulatory approval of a New Drug Application (NDA) or Biologics License Application (BLA). Additionally, the FDA guidance elaborates on how nonclinical information helps the Agency focus on important matters, such as:

 

  • Identifying pharmacological effects, including the mechanism of action of the drug in vitro and/or in vivo
  • Identifying absorption, distribution, metabolism, and excretion of the drug in vitro and/or in animals
  • Identifying possible consequences of exposure duration (e.g., chronic)
  • Identifying risks for special populations (e.g., pediatrics)

 

Regulation Examples

 

The FDA guidance goes on to describe unique conditions in which sponsors have successfully used GASK in their product development program. Each sponsor cited these GASK resources to meet FDA’s regulatory approval requirements instead of conducting certain nonclinical studies:

 

  • Products containing a substance that naturally occurs in the body. Sponsors submitted GASK regarding that substance and the known effects on biological processes.
  • Demonstrated drug impact on a particular biological pathway. Sponsors submitted GASK regarding the impact and FDA regulators concluded specific nonclinical studies were not necessary to support drug approval and drug labeling.

 

Active Ingredient

 

The FDA guidance continues by listing examples of substances that are typically present in a healthy human body. For example, endogenous substances where the drug replaces a substance that should naturally be present but, for pathological reasons, a patient may lack sufficient amounts. The FDA approved drug may enable and help accelerate the proper functioning of the human body.

 

Pharmacological

 

Additionally, a key driver of using GASK for FDA approval is the patient who has been prescribed a drug & the pharmacological impact experienced. Existing human pharmacokinetic studies and toxicology studies are recommended and may support the approval of the regulatory application. Specifically, regulators wil look to examine if the drug helps increase the level of the endogenous substance to the level of a healthy individual.  

 

Diet

 

Further, exogenous substances that are already present in a patient’s diet may help expedite U.S. Food and Drug Administration approval. This scenario includes a patient’s exposure to an unmodified food substance that doesn’t exceed typical levels of dietary exposure when the drug is taken orally. The FDA guidance also states that certain nonclinical studies may be unnecessary based on the relevance of the exogenous substance to the clinical research submitted. 

 

New Drug Application

 

If an FDA sponsor utilizes GASK information in their new product application, they must submit justification in the appropriate regulatory submission filing (e.g. BLA submission, 510(k) submission, etc.). The FDA guidance recommends as early as possible in product development to the assigned FDA regulator.

 

Finally, food and drug regulation feedback would be provided to the sponsor for the proposed regulatory strategy for approval. The FDA submission should incorporate evidence for the use of GASK, including textbook excerpts and/or non-product-specific published literature.

 

About Regulatory Compliance Associates (RCA)

 

Regulatory Compliance Associates (RCA) provides life science consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

 

fda guidance

 

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. Our life science consultants 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
  • 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®.

 

fda guidanceSotera 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.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory 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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® will guide you through every 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 four 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, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

 

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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants 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.

 

  • 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. We 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.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA® can help prepare a comprehensive 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’s Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves 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 life science consultants — 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®, 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® ‘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, Health Canada & MHRA 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®‘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 life science 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 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are 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® 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® life science consultants 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 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

 

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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