Manufacturing Consultant Services
Many professionals in the pharmaceutical sector 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.
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.
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.
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
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 manufacturing automation consultants with deep industry experience including:
- Validation Master Plan
- Development of Validation Documentation
- Validation Services
- Risk Assessments
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 in order to implement corrective action wherever it may be needed.
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. 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.
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.