Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries. Our compliance specialists work closely with our clients and the FDA to support the clients’ needs and requirements. We offer our clients a unique blend of technical expertise, compliance insight, and practical hands-on operating experience. Focus has the resources to meet your project needs in the most cost-effective manner.

Quality Systems

The quality system is the lifeblood of any regulated entity and our staff is trained, experienced, and knowledgeable in the establishment, implementation, monitoring, and management of change for quality systems. Areas for service include:

  • Quality Assurance Planning
  • Standard, Policy, and Procedure Development and Implementation
  • Quality System Internal and Supplier Audits
  • Mock Inspections

Process Validation and Equipment Qualification Services

The methodology by which a process is demonstrated to be under control and consistently produce an active ingredient with the desired strength, purity, and stability is encompassed in process validation.  With the implementation of serialization, the identity and information tracking for production from raw material to patient delivered product has only intensified the validation requirements.  Focus services for validation include:

  • Validation Life Cycle Methodology
  • Standard Operating Policy and Procedure Development/Implementation
  • Validation Master Planning
  • Project Validation Planning
  • Validation Gap Assessments
  • Process Validation
  • Equipment Qualification
  • Protocol Development and Execution
  • Validation Protocol Optimization
  • Documentation Management (EQ, DQ, IQ, OQ, PQ, and Final Reports)
  • Change Control
  • Re-Validation Planning
  • Critical Facility and Utility Qualification/Validation (Water, Steam, Gases, Compressed air, Temperature, Humidity)
  • Environmental Monitoring Planning and Execution (Particulate Matter Control Planning, Sampling and Analysis Plans, Analytical Data Review)
  • Cleaning Validation
  • Validation Training
  • Computer and PLC System Validation

Risk Assessment / Risk Management Services

The FDA’s 21st Century Initiative is intended to integrate quality systems and a risk management approach into existing systems. Focus provides services and tools to assist clients in implementing a Risk Assessment/Risk Management Program within their company. In addition, Focus can help develop quality policies on risk assessment for your company, and then revise any necessary existing guidance documents and SOPs.

Corporate On-Site Training / Seminars

Focus subject matter experts provide training and seminars on a variety to topics applicable to compliance for the pharmaceutical industries.

Response to Agency Actions

Focus assists our clients with their response to agency actions including inspection observations, 483s, warning letters, and notices of violation (NOV).  Focus assists with identifying and addressing the underlying issue, developing approaches to resolve the issue, preparing the remedial action plan and schedule, monitoring progress and reporting of the selected solution, testing the solution, and evaluation of completeness.