GXP Service 

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Developing and implementing successful
GXP quality systems and compliance strategies are what we do best.

MWA affords you flexible, scalable resource options and solutions to meet your regulatory needs. Our consulting services integrate seamlessly with your operations and provide targeted, expert resources on demand.

Excellence in GXP QUALITY SYSTEMS and COMPLIANCE STRATEGIES

The pharmaceutical, medical device and biotech industries occupy a unique position in the business world. You have a special relationship with the people who use your products. It can be a life-saving relationship, where safety and efficacy depend on compliance to FDA requirements. MWA takes this responsibility seriously.
MWA shares in your commitment to quality and understands how critically important regulatory compliance is to the success of your business and to the health and safety of your customers. We stand ready to begin building a relationship with you that will address your specific regulatory requirements.


Contact us Today
Discover the power of partnership with Marion Weinreb
& Associates, Inc. and reach your compliance goals with
our expert consulting. We look forward to hearing from you.
Call 415.388.1695 or 866.497.7787 (toll-free)
Email: info@gxpsrus.com
For more information visit: www.gxpsrus.com


MWA SERVICES

Consulting

Analytical/Quality Control (QC) Support
Clinical and GCP Support
CMC and Regulatory Affairs Support
Compliance Audits and Assessments
FDA Strategies
Formulation Development
GCP, GLP, GMP, ISO and QSR Compliance
Manufacturing Compliance Oversight
Manufacturing Engineering and Support
Methods Development
Microbiology Support
Packaging Engineering and Validation
Part 11 Compliance
Pre-Approval (PAI) Auditing and Training
Project Management
Quality Systems/QA Development and Support
Technical and Document Writing
Training Programs: Standardized or Customized
Validation: Cleaning, Equipment, Process, Software

 

Training

(Standardized and Customized Programs)
Aseptic Techniques
Effective Writing
Equipment Qualification
Failure Investigations
FDA QSIT Audit Approach
FDA Regulations (GCP, GLP and GMP)
GMPs in Research and Development
GMP/QSR Training
Great Documentation Practices
HACCP (Hazard Analysis and Critical Control Points)
Interacting with FDA
Internal and External Auditing Techniques
ISO 13485:2003
Out-of-Specification (OOS) Issues
Overview of Methods Validation
Packaging and Labeling GMPs
PAI Preparation and Planning
Part 11 Compliance
QSIT Overview
Technical Writing
Validation: Key Concepts and Planning


Expertise for the Pharmaceutical, Medical Device and Biotech Industries

Since 1995, MWA has grown into a worldwide consulting firm. With our extensive consulting capabilities and over 160 associates strategically located throughout the US, Canada and internationally, MWA can assist you in meeting your regulatory goals in pre-clinical, development or commercial operations. MWA’s expertise in GCP, GLP and GMP compliance, coupled with a hands-on approach, delivers strategies and solutions that will meet the regulatory demands of the 21st century. We are committed to excellence in all aspects of the business and focus on establishing and maintaining strong partnerships and producing exceptional results for our clients.

Our experience ensures cost-effective and efficient service and the insight to anticipate and plan for your critical needs. We provide short and long-term consulting services like GXP audits, analytical/QC, validation, regulatory affairs support and much more.

Our creative solutions provide you with value-added options in addressing your strategic resource needs. In every case, we customize our services to the specific requirements of our clients to achieve their goals most efficiently.