Strategic Consulting

Medical Device Strategy

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® (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 — no matter your size or unique needs.

 

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

 

Medical Device 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. 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 Associates® 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 Associates® has helped clients from around the world develop stage-ready testing based on each product’s regulatory pathway.  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

 

Medical Device 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 Associates® 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 Associates as Your Medical Device Consultants

 

For more than 20 years, Regulatory Compliance Associates® (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 Regulatory Compliance Associates

 

Regulatory 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. 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 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. 

 

 

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