Placing QA/Compliance professionals specializing in aseptic processing, sterile fill/finish, cleanroom control, media fills, and complex bioreactor validation.
Sourcing experts familiar with small molecule manufacturing, including tablet compression, capsule filling, mixing/blending, and terminal sterilization validation.
Providing specialists who understand the quality standards and specific regulatory requirements (e.g., ISO 22716, FDA cosmetic regulations) unique to non-drug product manufacturing.
Supplying talent familiar with the evolving regulations and quality management systems required for legal cannabis and hemp operations, including cultivation, extraction, and processing.
Placement of professionals specializing in preparing sites for pre-approval inspections (PAI), responding to 483s and Warning Letters, and implementing corrective and preventive actions (CAPA).
Experts in designing, implementing, and optimizing QMS elements like document control, change control, deviation management, and training programs to maintain GMP posture.