Services

– Laboratory Management: Provide guidance on laboratory organization and management, including staffing, training, equipment procurement, and regulatory compliance.

– Pharmaceutical Microbiology Testing: Assist with the development and validation of microbiological test methods, as well as provide oversight of microbiological testing activities.

– Contamination Control: Establish, implement, and maintain effective contamination control programs to ensure the safety of your manufacturing processes.

– Aseptic Core Monitoring Programs: Develop, implement, and improve aseptic core monitoring programs.

– Environmental Monitoring: Establish and maintain effective environmental monitoring programs to ensure the cleanliness and sterility of your manufacturing environment.

– Microbial Data Deviations: Expertise in conducting investigations into microbial data deviations, and developing effective corrective and preventative actions.

– Cleaning Validations: Develop and execute effective cleaning validation protocols to ensure that your equipment is clean and free of microbial and chemical contamination.

– Equipment Qualification: Ensure that your equipment is properly qualified and in compliance with regulatory requirements.

– Stability Programs: Develop and implement stability programs to help ensure the long-term quality and stability of your products.

– Data Integrity: Provide guidance on data integrity issues and help ensure that your data meets regulatory requirements.

– Batch Record Review: Review batch records to ensure that they are complete, accurate, and in compliance.

– Product Disposition Decisions: Provide guidance on product disposition decisions, including those related to microbial contamination or out-of-specification results.

– Audit Preparation, Hosting, and Management: Help you prepare for regulatory inspections including hosting, SME, and back room preparation.