GMP Consulting & Risk Management | Harpexco

Consulting Services

Should you require specialized expertise to support you in organizing your projects or operations, we can assist you through our consulting services. Whether your project is at its feasibility, conceptual, detailed engineering, construction or validation phase, our team will be glad to support you in managing all associated activities. Here are a few of the consulting services we offer.

Risk Management

Unpredictable events arise during the course of any project. These events may have a positive or a negative impact on your project objectives, scope, schedule, cost or quality. Our experienced personnel will assist you in determining your risk tolerance and quantifying and mitigating those risks to make sure you are well covered for the unexpected.

Here are some of the services we deliver:

Risk Management Planning
Risk Identification and Evaluation
Qualitative and Quantitative Risk Analysis
Risk Response Planning
Risk Control
SWOT Analysis
Probability and Impact Matrix
Risk Register

GMP Compliance Assessment

We can support you in ensuring the state of your production facility is kept in compliance with the cGMPs. We will perform a thorough review of your operation compliance against 21 CFR Part 210, 211 (cGMPs), 21 CFR Part 11, etc., benchmarking your state of regulatory compliance against the industry. We will also support you by providing a remediation action plan and action list with a detailed implementation schedule and effort estimate.

GMP Pharmaceutical Consulting & Risk Management – Montreal, Canada