Services

CMM Validation & Engineering Solutions LLC specializes in Validation, Engineering, Project Management, Quality Assurance and General Manufacturing/Packaging Consulting Services for the Pharmaceutical, Biotechnology and Medical Devices industries.

Our scope of services includes, but is not limited to, the following area of expertise:

• Validation

·         Project Management

·         Validation Master Planning

·         Equipment Qualification (IQ/OQ/PQ)

·         Utilities Systems and Facilities Qualification

·         Computer System Validation Life Cycle

·         Process Validation

·         Packaging Validation

·         Cleaning Validation

·         Re-Qualification Program

·         Technical Documentation

·         Standard Operating Procedures Preparation

• Engineering

·         Project Management

·         Project Engineering

·         Facility, Utilities and Equipment Commissioning

·         Factory Acceptance Test (FAT)

·         Preventive Maintenance Procedures Preparation

·         Standard Operating Procedures Preparation

·         Project Management

·         Overall Project Supervision

·         Project Scheduling

·         Budget Control

·         Regulatory Services

·         Laboratory Support

·         Laboratories Equipment Qualification

·         Laboratories Methods Validation

·         Investigations, CAPA’s and Technical Writing Development

·         Standard Operating Procedures Preparation

·         Quality Audit and Compliance Support

CMM Validation and Engineering Solutions LLC is pleased and proud of providing quality services to many major manufacturing, pharmaceutical and biotechnology industries. Here is a list of some of our clients.

·         Janssen – Gurabo

·         McNeil – Las Piedras

·         Amgen – Juncos

·         Dupont Pharmaceutical - Manatí

·         Bristol-Myers Squibb – Manatí

·         Watson – California