About Probity

Probity Consulting, Ltd, headqaurtered in Columbus, Ohio has been providing professional consulting services in cGMP Validation & Quality Assurance to the Pharmaceutical and Biotech industries.

We provide expansive guidance and expertise in areas including Production and Process Controls, Laboratory Constrols, Records and Reports System, Air & Water, Sterilization, Laboratory controls, Equipments, and Computer Systems.

Our goal is to remain the industry leader in providing excellence in compliance and validation products and services while maintaining our integrity.

We have grown over the years and diversified; adapting to our client needs to assure consistent and quality products and services to our valued clients.

Our Services

1.VALIDATION SERVICES

1.1 High Level Validation Design Service for unique and novel processes, equipment, systems

· We provide high level validation design services for unique and novel processes, equipment, and systems. We can guide and assist you in developing innovative validation study approaches & methodologies for customers with unique products and processes for which traditional approaches to validation studies may not be effective. We can also direct the completion & maintenance of your validation program in conjunction with your current GMP & QA system.

1.2 Technical evaluation of existing validation documents

· We provide technical evaluations of existing validation documents. We specialize in validation study documents and data review services for customers wanting to improve the effectiveness of their validation studies. We can review your existing validation packages to determine if the study is accurate, sound, and effective in the context of GMP compliance, scientific conformity, and QA practice and propose steps for improvement..

2. GMP COMPLIANCE SERVICES

2.1 Quality system overview

· We offer quality systems overview. We can review your corporate quality system for efficiency and propose improvements. We will identify QA and FDA compliance problems and then guide you through the resolution of these issues.

2.2 GMP training Services

· We can provide topic specific GMP training & educational seminars to increase the capabilities of your staff.

3. US AGENT SERVICE

As your US Agent, we provide the most diligent services for DMF holders.

4. USA – KOREA TECHNICAL BUSINESS LIAISON SERVICE

We can effectively represent your company and business partners in cases of technical communication, review and evaluation, and business development with US and Korean firms.

Contact

Phone: 614.500.3631

Fax: 614..454.1988

Email: tjpaik at consultprobity dot com