M W A C O N S U LT I N G , I N C. | Q U A L I T Y W I T H V I S I O N

CO N S U LT I N G S E R V I C E S

CO N S U LT I N G E X P E RT I S E I N Q UA L I T Y S YS T E M S A N D

G X P CO M P L I A N C E

E XC E L L E N C E I N G X P Q UA L I T Y S YS T E M S

A N D CO M P L I A N C E S T R AT E G I E S

Developing and implementing successful GXP quality

systems and compliance strategies are what we do best.

MWA a�ords you �exible, 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.

T h e p h a r m a c e u t i c a l , m e d i c a l d e v i c e a n d b i o t e c h

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 e�cacy depend on compliance to FDA requirements.

MWA takes this responsibility seriously.

.

M WA s h a r e s i n y o u r c o m m i t m e n t t o q u a l i t y a n d

u n d e r s t a n d s h o w c r i t i c a l l y i m p o r t a n t r e g u l a t o r y

complance 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

y o u r speci�c regulatory requirements.

CONTACT US TODAYDiscover the power of partnership with

MWA CONSULTING, INC.

and reach your compliance goals

with our expertise in consulting.

We look forward to hearing from you.

CALL (toll-free) 866.497.7787

Email: info@gxpsrus.com

For more information:

visit www.gxpsrus.com

E X P E RT I S E F O R T H E P H A R M AC E U T I C A L ,

M E D I C A L D E V I C E A N D B I OT E C H I N D U S T R I E S

MWA SERVICES

• 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

• 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

Since 1995, MWA has grown into a worldwide consulting

firm. With our ex tens ive consult ing capabi l i t ies and

over 160 associates strategical ly 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.

M W A C O N S U LT I N G , I N C. | Q U A L I T Y W I T H V I S I O N

CO N S U LT I N G S E R V I C E S

(Standardized and Customized Programs)

Consulting