The following is the most recent list of services provided by Regulatory Compliance Associates. We are continually updating and expanding our expertise, so if you have a question or you don’t find exactly what you are looking for, please call us at
(262) 842-1250 or e-mail us at info@rcainc.com.

Click on the topic headings below for faster browsing.

• Quality Systems
• Validation
• Regulatory Affairs
• Regulatory Submissions (Domestic & International)
• Risk Management
• CERT™ Risk Revenue
• Facility and Utility Qualifications
• Quality Audits
• Product Development
• Project Management
• Manufacturing Optimization
• Mergers & Acquisitions
• GxP
• Training
• e-Learning

Quality Systems
Building quality into every stage of product and process is essential to a company’s success. RCA can provide you with the staff and tools needed to implement or remediate your quality systems to current industry standards and train your personnel to manage it.

• Document Control Systems Implementation and Remediation
• Change Management Systems Implementation and Remediation
• CAPA Systems Implementation and Remediation
• Nonconforming Material Systems Implementation and Remediation
• Complaint Handling Systems Implementation and Remediation
• Validation Life Cycle Systems Implementation and Remediation
• Quality and Regulatory Training
• Standard Operating Procedure Development
• Risk Management (ISO 14971, ICHQ9)
• Supplier, Regulatory Compliance Audits

Validation
RCA has decades of experience working in the life science industries, assessing compliance and risk-based strategies, along with authoring, executing, and summarizing validations. We focus on a risk-based approach to identify the proper level of validation for your facilities, utilities, equipment processes, and computer systems. We can guide you every step of the way from the Validation Master Plan, through SOPs and protocols, to FDA approval. Examples include, but are not limited to:

Cleaning Validation
RCA engineers will insure that your specific cleaning process meets predetermined limits to prevent chemical or microbial contaminants that will affect the safety and quality of your products.

• Cleaning Validation Master Plans
• Determination of Effective Equivalency Strategies
• Protocol Development and Execution
• Determination of Sampling Methods and Plans
• Swab and Rinse Recovery Studies
• Analytical Test Method Development and Validation
• Establishing Residue Limits and Sample Acceptance Criteria

Computer and Software Validation
Our computer validation experts and software engineers have extensive experience with the GAMP4 validation model, to insure that you have the appropriate level of documentation.

• 21 CFR Part 11 Electronic Records, Electronic Signatures Validation
• Laboratory Systems Validation
• Network Infrastructure Validation
• Automation and Control Systems Validation
• Off-the-Shelf and Custom Software Validation

Legacy System Validation Remediation

• System Gap Analyses and Audits
• Risk Assessment
• Remediation Plan Implementation
• Quality Process Improvements
• Revalidation

Process Validation
There have been many guidelines published and almost as many opinions regarding the requirements for an acceptable process validation. Areas that need to be addressed include:

• When is process validation required?
• What procedures are required to support process validation?
• How is a risk-based process validation performed?
• When is revalidation of a process required? What is the validation life cycle?
• Can equivalency be used to streamline the process validation effort?
• What part do statistics play in a process validation?

Regulatory Affairs

• Regulatory Strategies
• Product Classifications
• Filing Preparation and Submission: 510(k)s, PMAs, IDEs, NDAs, INDs
• International Registration
• Recall Procedures
• FDA Warning Letter, 483 Remediation
• ISO 13485 and EMA Compliance
• Drug NDA/IND Approach and Preparation

Regulatory Submissions (Domestic & International)

Regulatory Compliance Associates Inc. helps navigate the constantly changing domestic and international regulations to successfully register your medical devices, IVDs, biologics, and pharmaceuticals.

• Determining whether registration is required
• Regulatory Strategy (drug and medical devices)
• Domestic and international establishment registration
• Product classification
• Technical writing [510(k) submissions, PMA submissions, de Novo, New Drug Applications, Generic Drug Applications, Drug Master Files (all types), Technical Files, Clinical Reviews, Explanation letters, etc.]
• Creating Submission Packages
• Follow-up and question resolution
• Audit support

Risk Management

• Hazards Analysis
• Risk Analysis: FMEAs, Fault Tree
• Risk-Benefit Analysis
• Risk Mitigation in Design Verification
• Design Validation and Process Validation
• Risk Management Maintenance Over Product Life Cycle

CERT™ Risk Revenue

Is Your Product PortfolioCERT™ Risk-Managed?

Most organizations focus risk management on their best-selling products orduring the development process. Then acquisitions occur, or the portfolioevolves into something more than the sum of its parts. A crisis periodicallyhits the news, prompting stakeholders to ask if their portfolio is riskmitigated. They’re looking for answers beyond traditional failure analysis.

CERT Risk-Revenue is a proprietary program that evaluates risk relativeto rewards for a company’s entire portfolio. Our seasoned experts helporganizations use CERT to manage risk/reward tradeoffs and to developmitigation strategies as needed before bad news hits home.

• 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

ASQ-CAQ or RAB-QSA certified auditors are available for the following:

• Document Control Systems Implementation and Remediation
• Supplier Audits
• cGMP Compliance Audits: manufacturing, pilot plant, laboratory facilities
• cGLP Compliance Audits
• Regulatory Gap Analyses
• Risk Assessment
• Pre-Approval Audits
• 21 CFR Part 11 Gap Analysis
• Development of Inspection Checklists

Product Development
From concept through launch, RCA can plan and execute your medical product development requirements. Or, we can review existing projects, as well as your research and development procedures, and provide training to streamline processes and help insure success.

• Project Leadership
• Prototype Development
• Risk Analysis
• Integration of Risk Mitigation into Product Development
• Design Verification and/or Validation Test Protocols
• Design Review Planning and Facilitation
• R&D Process Optimization for Increased Effectiveness and Efficiency
• Design and Development Standard Operating Procedure Development
• Regulatory Analysis and Filling Strategy Development
• Design History File Compilation
• Expert Problem Solving
• Design for Six Sigma

Project Management
RCA’s team of experienced certified project management professionals organize and manage resources to insure that projects are completed successfully, on-time, and within budget.

• On-site Project Leadership or Project Management Support
• Design and Implementation of a Project Management Office
• Project Planning Workshops
• Project Management Training
• Project Assessment, Remediation, and Follow-up
• Advanced Schedule Optimization and Management
• Development and Implementation of ANSI Compliant Methods
  • Risk Management
  • Issues Resolution and Decision Tracking
  • Change Management
  • Performance Measurement and Tracking
• Tool Selection for Program Portfolio and Resource Management

Manufacturing Optimization 
Our comprehensive evaluation will identify opportunities that consistently yield a sustainable return on investment.

RCA 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

Mergers & Acquisitions
When a life science company considers a merger or acquisition, it is easy to think of the deal’s risk as potential conflict with the FDA or its equivalent in other countries. The due diligence team looks for 483s, Warning Letters, notified bodies and findings, and product recalls. But more often, the real reasons a deal doesn’t deliver value are strategic, cultural, or technical. It’s these value-destroying areas that need to be explored during due diligence.

• M&A and Integration
• Due Diligence
• FDA Risks, Product Availability, Manufacturing Capacity, Systems Issues, Supplier Security, Management Stability, Pipeline Approval, Global Registrations
• Systems Consolidation
• Polices & Procedures, IT/Databases, Documentation
• Facilities
• Product Line Rationalization, Equipment Process Transfer
• Remediation
• Quality Systems, Design History Files, Technical Files, Validation, Product Regulatory Registrations

GxP
Includes:

• Good Manufacturing Practices
• Good Documentation Practices
• Good Clinical Practices
• Good Laboratory Practices

Training
Proper training is key in a regulated environment. Regulatory Compliance Associates Inc. has a training program that suits your professional needs, company goals, and preferred learning style. On-site or on the internet.

• RCA Short Courses
• International GMPs and Quality Assurance
• GMP for Manufacturing Operations
• Validation Principles
• Good Quality Control
• Laboratory Practices
• Good Contamination Control
• Risk Management in the Pharmaceutical Industry
• Validation Practices
• SOP Training

• GMP Series
• Lab Series
• Validation Series
• IT/IS Series
• QC Series
• Medical Device Series