Regulatory Compliance

Knowing the latest regulatory issues and rules/regulations is important for meeting compliance. GMP trends and FDA proposed concerns are constantly evolving and typically becoming more stringent. Keeping up on regulatory issues is a major focus of AKA. During facility planning, AKA can assist in design review, preconstruction FDA review, master planning, and on-going review for compliance during construction.


Often a company has the manpower to execute the protocols but not the time to write them. AKA can assist your firm by writing validation protocols for installation qualification, operational qualification and performance or process qualification. The protocols will address current industrial standards and comply with the FDA's cGMP guidelines. Having a master validation plan describing a firm's project and validation goals is very useful in the early stages of a project. Master validation plans describing the technical aspects, equipment and processes acceptance criteria, and other project related issues can be compiled by AKA for your firm.

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AKA can help you and your company in the following areas by performing or offering assistance in:

  • GMP Audits
  • Master Planning
  • Project Review and Management
  • Design Review
  • Validation Issues and Concerns
  • Quality Assurance/cGMP Compliance
  • Regulatory Compliance Issues
  • Protocol Writing
  • Document Control
  • Standard Operating Procedure Writing
  • Preventive Maintenance Programs
  • Calibration Programs

Areas of Expertise

Aseptic Processing and Sterilization
Environmental Control
Isolation Technology
Sterilization Technology
Bulk Pharmaceuticals
Solid Dosage Forms
Chemical Product Manufacturing
Quality Assurance/Quality Control