N&CS Consulting Group

Year Founded: 2010

• N&CS Consulting Group Inc. was founded in Puerto Rico, on September 2010 with one primary goal: to provide our customers with business solutions that can help them achieve GMP compliance and process excellence. We are driven to reduce process non-conformances, regulation violations, compliance gaps and any other process aspect that could lead to customer complaints, unplanned product dispositions, product recalls or even worse, federal government fines and/or warning letters than can affect your company confidence and credibility.

Type of Business:

• Consulting – Engineering & Regulatory Compliance Based Services, Manufacturing Management, Capital Project Management (PMO)

Principal Services:

• Regulatory Compliance/Validation, Pharmaceutical Manufacturing, Equipment Support, Project Management, Engineering Services, FDA Remediation projects, FDA 483 and Consent Decree. >

State of Incorporation:

• San Juan, Puerto Rico, September, 2010
• Georgia Foreign Corporation Certificate of Authority, 2015
• Florida Foreign Corporation Certificate of Authority, 2016

Size Jobs:

• 3K to 10MM

Company Retention Rate:

• BCS retention rate is 90%. Our employee salaries and benefits are very competitive relative to industry standards.

Minority Business Certification:

• Certification #PR02088

GxP Consulting Services

We offer the following GxP Consulting Services:

• GxP Documentation
• Validation Lifecycle Deliverables
  • Change Control, Validation Planning, Requirements, Documentation, Execution, Release and Closing
• Process Validation
• Cleaning Validation
• Manufacturing Equipment Validation
• Solid Dosage Manufacturing
  • Parenteral Manufacturing
  • Standards / Guidelines
  • Laboratory
  • Medical Devices
  • Biologics
  • Specialized
• Computerized System Validations
  • PLC's, SCADAS, MES, EPES, LIMS, BMS, CMMS, CNC, Software, etc...
• Facilities / Utilities Commissioning and Validation
  • Boilers, and Subsystems (Pumps Skid Systems, Deaerator, Surge Tanks, etc…)
  • Compressed Gases Systems (Air, Nitrogen, etc...)
  • HVAC
  • Water Generation, Treatment, Distribution
• Monitoring Studies
  • Environmental Mappings (Chambers, Ovens, Refrigerators, Warehouses, etc...)
• Sterilization Validation
  • CIP, SIP, GAMMA, ETO, Autoclaves
• Manufacturing Engineering Consulting
  • Process Engineering, Time Studies, Capability Analysis, Lean Manufacturing, Six Sigma, Cost Reduction, Process Excellence, etc…
• Instrumentation / Calibration
• CAPA / Non-Conformance, Complaints Investigations
• Project Management
• Design and Drafting Services
• Space Planning

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