Consulting

Not only training and books

Even though we are specialized in developing and presenting compliance training related to current US GMP regulations and FDA requirements, we do offer consultancy in different levels.

Consultants can either be our own training specialists or consultants from our partners or affiliates. Depending of the scoop of the consultancy assignment, availability of consultants, level of expertise and time frame, we will be able to propose a proper solution for your company.

Even though the services offered above are a comprehensive list of possible assignments we cannot always meet your requirements. Even so we will be able to help to get in contact with the right consultants or organisations.

If you need to get in contact with one of “our” consultants or to try if we might have the solution for your company, please send us an e-mail with your requirements. Of course we will treat all information received as confidential and it will not be revealed to any third party prior your approval.

For more information, specify your needs and contact us via e-mail info@key2compliance.com or phone +46-(0)8 544 811 60.

Areas of consulting

Compliance & Technical Audits:

• Internal GMP Audits

• Mock FDA Inspections

• Pre-approval (PAI) Inspection Audits

• Contractor Audits

• Audit Program Development

• GMP Compliance Evaluation

• Research and Development Compliance programs

Quality Assurance:

• Change Control System

• Quality Assurance Programs

• Document Control System

• Product Annual Review Program

• GMP & Technical Training Programs

• Batch Record Review System

• Process Deviation Investigations

• Product Failure Investigations

• Batch Release/Rejection Evaluation

FDA Compliance:

• Responses to FDA Letters & FD-483’s

• Responses to FDA Regulatory Actions

• Correction of FDA Observations

• Representation at FDA Meetings

Validation:

• Design of Validation Studies

• Review of Validation Protocols & Reports

• Validation Data Review

Facilities:

• Compliance Review of Facilities & Equipment Design

• Coordination for FDA Review & Approval

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