Services
Services listed below are not all- encompassing, request a consult to better understand all available services.
Regulatory
This track focuses on robust documentation management and submission to federal authorities/notified bodies for specialized industries.
Data Transformation
This track focuses on traceability with the goal of preventing or mitigating Corrective Actions and Preventative Actions observed by auditing firms.
Market Expansion
This track focuses on building a requirements dossier with the goal of legally operating in new regions.
List of Services (Non-Extensive)
Supply Chain
Standard Operating Procedures
Quality Manuals
Statement Letters
Internal Audit Frameworks
Risk Management Matrices
Root Cause Analysis
Organizational Mapping
Continuous Improvement
Regulatory Affairs
Traceability Matrices
FDA Submissions ¹
CE Marking ²³
Ministry of Health submissions ³
Business Analysis
Horizon Scanning (Industry Trend Analysis)
Technical Upgrades
Data Management
Data Translation
Data Transformation
Industries Served
Consumer Packaged Goods (CPG)
Food, Beverage, & Confection
Industrial
Beauty & Cosmetic
Medical Devices (MDR & IVDR)
Pharmaceutical, Nutritional & Life Sciences
¹Food and/or Drug/Medical Device Manufacturing exclusively.
²European Union (EU) exclusively.
³Drug, Medical Device, and Pharmaceutical Manufacturing exclusively.
Industrial
Medical Devices
Consumer
Packaged Goods
Beauty
& Cosmetics
Food, Beverage
& Confection
Pharma,
Nutritional
& Life Sciences
Request a Consultation
Not sure where to start? Request a consultation so we can better understand your needs
and find a strategy that works best for your business.
Frequently Asked Questions
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You would require a regulatory affairs service or supply chain service contingent upon your processes and industry. This service also spans Quality where our consultants will map your internal processes and provide your customers with transparency regarding your company's workstream.
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Our consultants can educate your staff on the facets of California Proposition 65 and review your product catalog to ensure your products meet the requirements necessary to sell within California.
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No worries! Our team will review the observations/actions provided to your company and develop a risk management matrix to fix current issues and solve them at the root. We will also draft the necessary internal documentation to mitigate future risk.
Have a Question We Didn’t Answer?
Contact Us
E-mail: Hello@mack-consulting.net | Location: Chicago, IL 60637