Pharmaceutical Manufacturing Consultants

Manufacturing Consultant Services

Many pharmaceutical manufacturing consultants believe that the financial wellbeing of a company lies primarily in its research and product development. However, the truth is that just as many gains can be won by taking a critical look at a company’s pharmaceutical manufacturing processes, equipment and overall operational footprint. Because (from startups to world-class organizations) the focus lies so much on new product development, the optimization of existing manufacturing processes, as well as the techniques and equipment employed, is often an afterthought — if it’s even thought of at all.

Drug Manufacturers

Industry 4.0 is driving more efficiency through trends such as automated processes, data exchanges, and new manufacturing technologies like “smart factories”. Drug manufacturers know the optimization of pharmaceutical manufacturing operations isn’t just about cost savings — it’s also about embracing the business model of the future.

Pharma Manufacturing

Just like companies can no longer overlook customer experience (CX) and the insights they can glean from the CX data they collect, they also can’t relegate the efficiency of their manufacturing facilities to a mere compliance issue. Thanks to digital technologies like the Internet of Things (IoT) and robust analytical applications, organizations can now transform everything from their supply chains to their factory floors into more agile, productive, and lean operations — and add more value to the entire enterprise.

Pharmaceutical Manufacturing & Optimization

Regulatory Compliance Associates strategic consulting services extend to manufacturing process optimization for maximum impact on your bottom line, manufacturing automation for adequate validation of equipment, and validation process for aging facilities to ensure quality, cleanliness, compliancy, and safety.

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

RCA^® 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

RCA^® provides pharmaceutical manufacturing consultants with deep industry experience including:

Validation Master Plan
Development of Validation Documentation
Validation Services
Risk Assessments

Factory Automation

RCA^® helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facility 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.

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 step of the regulatory process. Our pharmaceutical manufacturing consultants will 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 pharmaceutical manufacturing consultants 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 pharmaceutical manufacturing consultants 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 p pharmaceutical manufacturing consultants know 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 pharmaceutical manufacturing 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, Regulatory Compliance Associates 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.

Pharmaceutical Manufacturing