黄人导航

Strategic Consulting

黄人导航 Strategy

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance 黄人导航 (RCA) 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 medical device strategy 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 鈥 no matter your size or unique needs.

 

We offer many strategic consulting services to guide you through the medical device development process, such as:

 

黄人导航 Manufacturing and Facility Optimization

 

When you take the time to evaluate your manufacturing processes, you’ll often find new ways to optimize as you discover how these methods relate to your bottom line. We help you maximize your manufacturing processes and validate aging facilities to ensure continual compliance with industry standards.听These services include:

 

  • Solutions to increase throughput and efficiency in the lab
  • Strategies to reduce set-up times, inventory levels, waste and costs
  • Risk assessments
  • Manufacturing automation
  • Validation of aging equipment and facilities

 

New Product Development

 

The development of a new product comes with many challenges to overcome. You have to stay within growing industry regulations and internal quality standards while speeding up the development cycle for a quick time-to-market. Regulatory Compliance 黄人导航听helps you meet these challenges with new product development services such as:

 

  • Outsourced quality and regulatory support
  • Project and risk management
  • Design input and output
  • Post-market surveillance

 

Lab Testing

 

Regulatory Compliance 黄人导航听has helped clients from around the world develop stage-ready testing based on each product’s regulatory pathway.听 Our pharmaceutical testing services include supporting pre-formulation, process development for formulation, and formulation manufacturing. The following includes a high level overview of solubility and dissolution testing, stability testing, solid form testing we conduct for new product development clients.

 

Product Lifecycle Management

 

Your product undergoes a series of changes from the idea’s conception through development, sales and the end of its life cycle. You can more efficiently manage these changes through product life cycle management (LCM). We offer many strategies to ease any challenges you might face throughout the life cycle, with services including:

 

  • Change management
  • Post-release risk management and regulatory support
  • End-of-life strategy

 

黄人导航 Staffing Support

 

Every company goes through staffing changes throughout its lifetime, and whether you’re undergoing a temporary staffing issue or need to outsource after a disruptive crisis, Regulatory Compliance 黄人导航听can help. We offer staffing support services such as these to help you manage your resources and ensure your projects are completed effectively:

 

  • On-site project leadership or management support
  • Staff Augmentation
  • Solution implementations for specific projects
  • Consulting support

 

Mergers and Acquisitions / Due Diligence

Before you move forward with an M&A deal, you need a clear understanding of the associated risks and benefits. We’ll help you determine the value of a deal as we evaluate the target business to ensure the right fit with your company. We offer M&A and due diligence solutions including:

 

  • Regulatory and quality due diligence
  • Facility and equipment assessments
  • Personnel assessments
  • Post-merger integration

Choose Regulatory Compliance 黄人导航 as Your 黄人导航 Consultants

 

For more than 20 years, Regulatory Compliance 黄人导航 (RCA) has guided both small and large medical device companies towards optimization and industry compliance with an array of strategy consulting services. Our experienced team is here to create a consulting solution tailored to the needs of your business and the changing demands of your industry. Partner with us as we guide you through every stage of company growth and compliance with the ideal solution to help you reach your goals.

 

About RCA’s 黄人导航 Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance 黄人导航 can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts 鈥 including former FDA officials and regulatory compliance leaders in the field of medical device regulation 鈥 will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance 黄人导航 works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

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 Regulatory Compliance 黄人导航 medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance 黄人导航, 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, Regulatory Compliance 黄人导航 medical device consultant Experts can help strengthen your device鈥檚 cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance 黄人导航 backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts 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 represent Regulatory Compliance 黄人导航 as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance 黄人导航 medical device consulting company has expertise in both the approval process and post-approval support.听

 

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

 

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 黄人导航 can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance 黄人导航 to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

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

 

Quality Assurance

 

Regulatory Compliance 黄人导航 Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance 黄人导航听medical device consultant is a quality expert 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 Regulatory Compliance 黄人导航, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance 黄人导航听trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

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

 

Remediation Services

 

Regulatory Compliance 黄人导航 is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance 黄人导航 ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

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

 

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 medical device consultant expertise and experience that makes partnering with Regulatory Compliance 黄人导航听 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 黄人导航medical device consultancy can help ensure a successful project. Regulatory Compliance 黄人导航 medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are 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 鈥 no matter your size or unique needs.

 

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

 

About Regulatory Compliance 黄人导航

 

medical device consultingRegulatory Compliance 黄人导航听(RCA) provides medical device 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 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.

 

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

 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue