SERVICES

Your Strategic Consulting Partner

READINESS

Are you ready for your next inspection, re-inspection, or pre-approval inspection? I’ve provided clients with a wide range of readiness tools, audits and training. To find out more, get in touch.

STRATEGIZING

My services are customized to meet the specific needs of each client. I work collaboratively throughout the entire process producing measurable results. We work together to develop right sized solutions to your most complex challenges. Contact me to find out how I can help today.

CONSULTING PARTNER

My clients are my number one priority, and my services prove just how committed I am to their success. Book an introductory meeting today to learn more about how I can support you, your team and your organization.

What We Do

medical devices

Class I, II, III

Diagnostics
Implants
Electronics
Plastics
Metals
Robotics
Digital

Sterilization - ETO, VHP, Gamma, E Beam

Design
CAPA
Risk Management
Metrics
Qualification
Verification
Validation
Management
Culture

QSR/ISO/MDR/IVDR

pharmaceuticals

OTC
Monograph
NDA
ANDA
NADA
ANADA

API
OSD
SVP
LVP
Solutions/Emulsions/
Suspensions
Type I Medicated Articles

Quality Unit Oversight
Production Controls
Qualification
Validation
Complaint Management
Metrics
Management
Culture

combination products

NDA
ANDA
PMA
510(k)
BLA

21 CFR PART 4

Pre-filled Syringes
Autoinjectors
Pens

MDI
DPI

Transdermal Patches

Drops

Integral

Kits

Cross-labeled

services and markets

Dietary Supplement cGMP

Biomonitoring/Sponsor-Monitor/IRB/CRO/CI

Cosmetics

Backroom Support

Training:
cGMP basic training
Preparing and Hosting an Inspection
Writing Responses
Investigation Management

GLOBAL MARKETS

US FDA

EMA

MHRA

HEALTH CANADA

HPRA