Remediation Services

Regulatory Compliance Associates has significant experience and a proven business consultant approach to managing FDA Warning Letters, Consent Decrees, and other serious remediation services. Our life science consultants know how to partner with executive, legal, and communication teams. Regulatory Compliance Associates medical consulting Experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute.

About RCA’s Pharmaceutical Remediation 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.

Each QMS consultant negotiates difficult demands of remediation services with insight and the clear advantage of our unique expertise and experience. Deep management consulting experience makes partnering with Regulatory Compliance Associates a competitive differentiator of good quality in the remediation services space.

Quality System
- Design Strategy Consulting
- ISO 9001 Consultant
- Quality System Consultant
Technical File and Design History File (DHF)
- Design Consultant
- Design Engineer Consultant
- Mechanical Design Consultant
- Product Design Consultant
Data Integrity
- Process Design Consultant
- Operations Consultant
- Experience Design Consultant
Regulatory Action
- Regulatory Consultant
- Sustainability Design Consultant
Manufacturing and Facility Validation
- Manufacturing Consultant
- Electrical Design Consultants
- Electronic Design Consultants
- Industrial Design Consultant
21 CFR Part 11 & Computerized System Validation
- Design Engineering Consultant
- Service Design Consultant

FDA Warning Letter Management

Regulatory Compliance Associates life science consulting Experts 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.

Our Pharmaceutical Remediation Strategy & Support services are organized to help you deal with circumstances as they unfold. We’re a remediation company designed to help your team understand the situation & a remediation strategy acceptable to the regulatory agency. Regulatory Compliance Associates can partner with you to manage plan execution and to help you stay in a compliant state going forward. Our healthcare consulting services include:

21 CFR Part 210 and 211

Continued compliance to 21 CFR part 210 and 211 — including current good manufacturing practice (cGMP) — is crucial during pharmaceutical manufacturing. cGMP compliance is especially vital if you’re looking to receive an FDA Certificate of Pharmaceutical Product.

Regulatory Compliance Associates is here to help you improve your adherence to cGMP and CFR part 210 and 211 if you’ve received a compliance violation. We’ll help you develop pharma solutions to maintain this critical compliance through our remediation services, including:

Complaints review and assessment
Laboratory operation improvements
Supplier quality programs and agreements
Investigations/CAPAs improvements

Regulatory Action

At Regulatory Compliance Associates, we understand the pharmaceutical consulting challenges that your business faces after receiving a warning letter from a regulatory agency. Our business management consultant Experts will develop a customized, comprehensive plan to address the regulatory issues following:

FDA Form 483
Warning letter
Consent decree

Oversight Services

When you need to remediate quality systems and manufacturing operations, we offer services designed to evaluate problem areas, determine a plan of action and provide assistance after implementation to ensure continued compliance. These pharma consulting oversight services include:

Auditing services to check for compliance gaps
Creating an action plan for cGMP areas
Supply chain consulting & manufacturing best practices
Improve manufacturing production practices and quality control

Data Integrity

Properly handling your pharmaceutical company’s data is vital. RCA’s remediation group provides a both GMP training and GMP consulting services that will help you manage data integrity and target any notable issues. These services include:

Training opportunities such as corrective action and preventive action (CAPA), good manufacturing practice (GMP), good documentation practice (GDP), and investigations
Consulting services like audits and development and implementation of a post-audit remediation plan
Tech consulting & IT consulting services

Manufacturing and Facility Support

Whether you’re installing new manufacturing equipment or face operations and equipment compliance challenges, environmental remediation is no laughing matter. Regulatory Compliance Associates offers brownfield remediation & validation programs tailored to meet the needs of your organization. Our pharmaceutical manufacturing services & facility support includes:

Validation of equipment, facilities and utilities
Re-validation of old equipment
Remediation of quality system deficiencies
Manufacturing consultant services

Our team of pharmaceutical regulatory affairs & computer validation professionals is well-versed in the GAMP5 validation model and can support the validation of a range of systems following a compliance challenge, including:

Network Infrastructure
Laboratory systems
Control systems and automation
Custom software
Strategic consulting

Laboratory Support

If you’ve recently received a 483 or warning letter — or if you’re starting to return to a normal state of business following a compliance crisis — your compliance of laboratory operations with cGMP is exceedingly crucial. Regulatory Compliance Associates offers remediation contractors & lab testing support services to keep your laboratory in compliance, such as:

Data integrity verification
On-site inspections
Risk assessments
Method development assessments
Business consulting services

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

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

Regulatory 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.

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