Design Review and Technology Transfer - We review process designs and scale-up to achieve optimal output and regulatory approval for you.

Time-to-Approval - Our regulatory guidance, FDA inspection readiness and submittal services accelerate validation and compliance procedures, i.e. time-to-market.

Validation Organization - This service evaluates your user requirements and leads to a design of the validation master plan. We organize the plan for systemic efficiency in your manufacturing process.

Yield Enhancement - Process plant surveys evaluate individual process steps to eliminate or reduce yield losses during downstream processing.

Process and Down-time Reduction - We investigate and analyze processes to mitigate bottlenecks and lag time within the process.

Capacity Utilization - We implement new technologies in downstream processing and processing controls to enhance process flow utilization.

Labor Efficiency - Appropriate training of your personnel supports process improvement initiatives and proper adherence to protocols.

Yield Improvement - We’ll show you how to maximize yield improvement with your existing process resulting in increased capacity.

Process Times/Flow Enhancement - Achieve efficiencies in your process with state-of-the-art equipment, upstream improvement process surveys.

Process Controls - Appropriate process controls avoid prolonged quarantines, reprocessing or production stoppage of your product.

FDA/EMEA/ISO Compliance - We also design and write validation and operating procedures. We also produce submittal documentation to regulatory authorities.

Quality Systems Audit - We review new or existing quality systems to improve process controls while meeting regulatory requirements.

Regulatory Guidance - We implement any regulatory requirements or changes within regulations and train personnel accordingly.

Documentation Submittal Support - We write protocols and filings for inspection by regulators to minimize delays in the approval process.