Pharmaceutical Supply Chain Consulting

About Regulatory Compliance Associaties

Regulatory Compliance Associates (RCA^® ) provides pharmaceutical supply chain 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, supply chain, 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 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.

RCA Pharmaceutical Supply Chain Consulting Services

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

Assessments

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA^® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

Our range of compliance consulting services includes:

cGMP & Pharmaceutical Manufacturing
Quality Infrastructure
PAI, Validation
Facilities and Maintenance
Laboratory (GLP)
Process Assessments to Streamline and Optimize New and Existing Systems.

Audits

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

Supplier
API
Contact Manufactures (CMO)
Internal
Quality Systems
Baseline
Verification
Clinical (CRO) and Clinical Manufacturing
Data Integrity
503A & 503B
Combination Products

Regulatory Agency Response

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

FDA Form 483
Warning Letter
Consent Decree
Import Bans

Preparation, Training, and Inspection Readiness

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA^® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
Response Letter Assistance
Proof Book Development
Business Relations (Leadership Development Training)
- Corporate Regulation Examples
  - Regulatory Law
  - Regulatory Board
  - Legal Compliance
Industry Relations (Leadership Development Training)
- Types of Regulation
  - Medical Regulations
  - Security Regulations
  - Cybersecurity Regulations
  - Data Compliance Regulations

Data Integrity

Training:

Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
Annual Good Manufacturing Practice (GMP)
Investigations
Corrective Action and Preventive Action (CAPA)

Consulting:

Comprehensive Audits
Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
Assistance with Execution of the Remediation Plan

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

cGMP Consulting

Maintaining data integrity is an important part of ensuring the manufacturing quality of your pharmaceutical. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for GMP quality compliance services.

With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.

GMP Quality Compliance Services

Training

Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
Annual Good Manufacturing Practice (GMP)
Investigations
Corrective Action and Preventive Action (CAPA)

Consulting

cGMP Consulting
Comprehensive Audits
Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
Assistance with the execution of Remediation Plan

In the event of an audit, the information gathered during the manufacturing of your medical device—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

Manufacturing Processes

Our comprehensive evaluations will identify GMP pharmaceutical practices that consistently yield a sustainable return on investment. We will help you identify opportunities for:

Reducing Set-Up Times
Increasing Throughput
Reducing Inventory Levels
Lab Efficiency Improvements
Scrap and Waste Reduction
Cycle Time Compression
Capacity Creation
Process Automation
Cost Reduction

Manufacturing Optimization

Regulatory Compliance Associates provides the following manufacturing optimization services:

Program Analysis
Process Optimization through Engineering Studies
Statistical Process Control
Lean Innovative Product / Process Solutions
Value Stream Mapping
Kaizen Events
Design for Six Sigma
Inventive Problem Solving

Automated Industrial Services

Regulatory Compliance Associates provides manufacturing automation consultants with deep industry experience including:

Validation Master Plan
Development of Validation Documentation
Validation Services
Risk Assessments

Factory Automation

Regulatory Compliance Associates helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facilities will continue to meet all regulatory and client requirements, without an adverse impact on the finished product.

HVAC Systems and Associated Controllers
Medical Gas Systems
Plant and Pure Steam Systems
Water Systems including USP, RO / DI, and WFI
Compressed Air Systems
Controlled Environments

Pharmaceutical Contract Manufacturing

When you choose Regulatory Compliance Associates as your pharmaceutical manufacturing consultant, you’ll have the support of validating every contract manufacturer. RCA provides the combined skills and knowledge of more than 500 pharmaceutical and medical device experts who are experienced at working on the front lines of regulatory requirements. RCA clients benefit as these solutions move suppliers toward a culture of quality, from startups to Fortune 100 international enterprises.

Quality Management System

To create a positive change in the lives of patients counting on the availability of your product, you need to recognize the regulatory pathways of drug manufacturing companies that are ahead of you. Further, this includes the evolving technical development of your quality management system. When you work with us, you get a team that tailors its services to the comprehensive needs of your company. And that’s how you can be assured you’ll always receive the support you need to implement corrective action wherever it may be needed.

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