Our Services

Consulting Services 

Project Manager/Consultant with extensive experience providing services in federally regulated environments. Team Leader with demonstrated project team management skills. Proficient in the following: 
cGMP systems Implementation, FDA 483/Warning letter remediation. Design, Develop, train, and implementation of Validated systems. Supplier evaluation and control systems, CAPA investigation and implementation of corrective actions, Post Market evaluation and reliability engineering. Demonstrated strong technical documentation and verbal communication skills, problem solving and interpersonal skills. Demonstrated ability to work independently or within a collaborative environment. Developed teams focused on improving key performance indicators, lead integration projects, and cost reduction initiatives. Analytical and known for personal credibility.

 - GMP/ISO 13485 Compliance

Let us help you achieve GMP and ISO 13485 compliance.
We can provide a broad range of services from validation protocols to product submissions as well as establishing the required documents to meet QSR and ISO 13485 compliance. 
As part of our services, we can assist you implement the following documentations and systems throughout your facility: 
Raw material testing and control ​Manufacturing SOPs and product history records ​Equipment and facilities validation protocols ​Process validation ​Quality Control procedures and release criteria generation ​Customer complaint handling and recall procedures ​Quality Systems Manual ​Labeling and quarantine SOPs ​Equipment SOPs ​Quality audit procedures ​Design validation and verification ​Sterility validation and verification procedures based on FDA recognized procedures. ​We also provide a variety of technical and regulatory services to manufacturers of medical devices, diagnostics, food, cosmetics, and drugs including: 
Full FDA submissions [510(k), PMA, PLA / ELA, IDE, IND, NDA] generated. ​Clinical protocols and study monitoring performed for Pharmaceuticals (Phase 1, 2, and 3), foods, cosmetics, diagnostic, and biological products. ​Preparation of CMC sections for drugs, food additives, cosmetics, or biologics. ​Submissions to USDA for animal diagnostics products. ​Assist in designing and writing toxicology and microbiology studies, safety and efficacy studies, and feasibility study reports. ​Documentation for process manufacturing and quality control testing written to comply with QSR/GMP/ISO 13485 and GLP. ​Validation protocols written and performed for processes and equipment. . ​Manufacturing process evaluation of drug, biologics, diagnostic reagents and products. Our past experience in manufacturing provides practical assistance in production scale up and process problem-solving. ​GMP and ISO 13485 audits performed to identify areas in which compliance may be weak or lacking. A report is submitted with recommendations for improvement. ​Investigational Device Exemption (IDE) for clinical trials of medical devices. ​Submission of various types of Biologic and Drug Master Files and DMFs for foreign device manufacturers. ​Orphan Product Submissions. ​Technical Dossiers. ​Registration document packages for registrations outside the United States. 
 Improvement Using the Six Sigma Methodology• Lean Enterprise/Manufacturing• ISO 9001 Systems Development and Assessments
• ISO/TS 16949 Automotive Quality Systems Development and Assessments• ISO 14001 Environmental Systems Development and Assessments• As 9100 Aerospace Systems Development and Assessments• ISO 13485 Medical Device Systems Development and Assessments• OHSAS 18001 Systems Development and Assessments• GMP Compliance• SPC Training and Implementation• Root Cause Analysis• Effective Implementation of Corrective and Preventive Action Systems• Data Analysis for Effective Problem Solving 
   -Training Workshops Available
An Overview of Six Sigma Approach to Process ExcellenceThis is an introductory course to the Six Sigma Methodology and the Define - Measure - Analyze - Improve - Measure - Control (DMAIC) approach to process excellence. This course is suitable for all employees in an organization. 


-Process Excellence and Total Quality Leadership:
Describes how Process Excellence and Total Quality change the way things get done in order to increase customer satisfaction and eliminate non-value added steps in processes. This workshop is suitable for all managers and supervisors in an organization. 

-Team Building:Helps individuals become effective team leaders and team members as well as manage group dynamics. This workshop is suitable for all employees in an organization. 
Process Excellence ToolsEnables individuals to use analytical tools such as run charts, Pareto charts, check sheets, cause and effect diagrams and flow charts in order to measure, track, control and improve critical process variables. This course is suitable for all employees in an organization. 

-Statistical Process Control:Enables employees to use SPC to analyze sample data and make appropriate adjustments in the process in order to reduce and control variation resulting in higher productivity. This course is suitable for all employees in an organization.
Team Approach to Problem Solving and ImprovementEnables individuals to learn team approach to problem solving and continuous improvement based on the Plan-Check-Do-Act improvement cycle. The course is suitable for personnel who serve on corrective action and/or process improvement teams.

Introduction to the ISO 9001 Standards​ Describes the new ISO 9001International Quality Management Standards and what it takes to become certified to these standards. 
IS0 9001 Internal Auditing Workshop​ Enables internal ISO auditors to become familiar with the new ISO 9001 Standards, process approach to internal auditing and the typical audit questions they should ask related to each clause of the new standards. 
Introduction to ISO 14001 Standards​ Describes the ISO 14001 Environmental Management Systems Standards and what it takes to become certified to these standards. 
IS0 14001 Internal Auditing WorkshopEnables the participants to become familiar with the ISO 14001 Standards and the typical audit questions they should ask related to each clause of ISO 14001. 
Introduction to ISO/TS 16949 Automotive Quality Management Systems StandardsDescribes the new TS 16949 Automotive Quality Management Standards and what it takes to become certified to these standards.
ISO/TS 16949 Internal Auditing WorkshopEnables the participants to become familiar with the new TS 16949 Automotive Quality Management Standards and the typical audit questions they should ask related to each clause ISO/TS 16949. 


                            

                                - ISO 9001 Certification 

        ISO 9001Quality Management System 
A new edition of ISO 9001 Quality Management System was released  
The new ISO 9001 revision maintains its Performance Excellence concept of continual improvement and customer satisfaction. It utilizes the “Plan-Do-Check-Act” improvement methodology and can be used as an excellent foundation for achieving Six Sigma level process excellence.  
If you already have your certification but are resource limited, we can offer you a certification maintenance program. We will periodically visit your facility to conduct the required internal audits, facilitate the management reviews, and follow-up on any corrective actions to make sure that you successfully pass your surveillance and recertification audits.


  

IntelliPro Systems
Intellingent Processing systems for Manufacturing and Quality