Operational Support

Compliance to 21 CFR is critical to the pharmaceutical & other regulated industries. This includes adherence to all forms of GxP by understanding the processes defined in FDA guidelines. Companies that require assistance in establishing, maintaining, or improving their systems are assured they will receive professional, reliable and actionable strategies from our experts. Operational support of your system can encompass many areas, including:

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• Standard Operating Procedures & Documentation Drafting

• Regulatory Writing

• Program Management

• Project Management

• Supplier Management

• Process Improvement

• Technology Transfer

• Development of Training Programs to various regulations

• Supplier Quality Programs, Quality Agreements & Quality Manuals

• Strategic Review & Assessment of the Organization

• And many others

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We can also assist with answering 483 observations and developing long term strategies that will help your organization maintain compliance through process and system improvements. Contact us today for your initial consultation.