Other Regulatory Services

Your pharmaceutical company can change millions of lives, but staff shortages among regulated companies in the life science industry often make it difficult to live up to full potential. When you need to increase productivity and decrease regulatory risks, regulatory services outsourcing provides an ideal solution.

 

At Regulatory Compliance Associates (RCA®), we offer a wide range of outsourced regulatory services to help you maintain your business operations — even after a compliance crisis or during a management turnover.

 

Regulatory Compliance Associates has the expertise to assist you with your unique regulatory needs. We understand that it’s not always government-regulated submissions or inspections our clients might need assistance with.

 

Outsourced Regulatory Services

 

In a competitive business world, pharmaceutical companies use regulatory agencies to often run lean on staff and resources. A staff shortage can slow normal business operations and make it difficult to deliver quality and timely solutions to your customers and end users. Instead, many companies choose to work with Regulatory Compliance Associates. for ongoing support or special projects where time and quality are of the essence.

 

With a team of more than 500 industry experts, Regulatory Compliance Associates can offer the assistance you need through large projects and management changes. You’ll find ongoing advice and support from an array of FDA consultant industry insiders who can help your business flourish as you successfully navigate stringent FDA guidelines.

 

We can assist Interim Management situations such as the company’s VP of Quality and Regulatory unexpectedly submitting their two-week notice, or another key QA staff member taking medical leave, or the start-up company needs strategic RA / QA insights, but isn’t ready for full-time headcount. Regardless of the size of the life science company, outsourcing quality and regulatory management can bring needed expertise while saving costs. We can provide outsourced management solutions to:

 

  • Operations
  • Quality
  • Regulatory
  • Medical Affairs
  • Product Development

 

Perhaps you don’t need interim staff, but you’d like to teach your current staff and executives about regulatory communication or regulatory compliance. RCA also offers a broad range of assessment, support, and training services, including:

 

  • Regulatory Gap Assessment
  • Regulatory Due Diligence Audit
  • Change Control Support
  • Regulatory Affairs Training—Proper training is key in a regulated environment. We have a training program that suits your professional needs, company goals, and preferred learning style.
    • Good Manufacturing Practice (GMP) Fundamentals
    • Quality System Regulation
    • International Medical Device Regulations
    • Good Documentation Practices
    • Quality Management Systems and Infrastructure
    • Management Responsibility
    • Risk Management
    • Complaints and Medical Device Reporting (MDRs)
    • CAPA and Root Causes Analysis
    • Design Control
    • Validation
    • Environmental Control
    • Calibration / Maintenance
    • Purchasing Controls and Supplier Management
    • Change Control
    • Document Control
    • Regulatory Submissions 510(k)
    • Non-Conforming Product
    • Technical Writing
    • Audits
    • Adverse Finding and Consequences
    • Criminal Offenses
    • Contributing To A Successful Quality Culture
  • Electronic Submissions Preparation in Electronic Common Technical Document (eCTD) format for FDA, Health Canada, and EMEA

 

Transform your business with Regulatory Compliance Associates

 

Your pharmaceutical company has the power to transform lives, but you first need to stay within regulatory guidelines and maintain compliance with global regulatory authorities. If you’re looking for the best way to bring needed regulatory services to your business at an affordable cost, turn to the regulatory outsourcing experts at RCA® Inc..

 

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, 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 regulatory compliance executives from 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 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 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 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 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
  • Data Integrity

 

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 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 Associates 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 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, each Regulatory Compliance Associates 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 Associates

 

pharmaceutical consultantsRegulatory 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®.

 

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 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 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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