Our Services
BioAcuity Consulting Inc. specializes in providing development, manufacturing, operations, quality, compliance and regulatory consulting services to manufacturers of plasma protein therapeutics, biologics, drug, medical device, natural health, and other healthcare products for human and veterinary use.
Below are some of the areas that we cover. Contact us for more information or to discuss how BioAcuity can bring our industry knowledge and world class operating experience to your business.
- Technical Due Diligence
- Quality Management Systems
- Operations Management
- Capital Project Management
- Program Management
- Manufacturing Strategy
- Business & Organizational Development
- Product Development & Commercialization Strategy
- Risk Assessment
- GxP and ISO Quality Management System Development & Implementation
- Lean Optimization
- Validation and Quality Master Planning
- Computer System Validation
- GMP/GDP/GCP/GLP Compliance Auditing
- Qualification & Validation
- Cleaning Validation
- Standard Operating Procedures (SOPs) Development, Implementation & Optimization
- Change Control and CAPA Process Optimizations
- Compliance Investigations
- Batch Records Review and Optimization
- GxP Training
- Supplier Qualification & Auditing
- Product Recall
- Facility Master Planning
- Conceptual Design Development
- Capital Project Management & Support
- Construction Management
- Facilities Optimization & Design
- Facilities Engineering (with Partners)
- Construction and Engineering Quality
- Process Scale-up
- Process Design & Optimization
- Process Engineering (with Partners)
- Vendor Qualification & Auditing
- Design Compliance Review
- Commissioning
- URS,FS, DS, DQ, FAT/SAT
- Validation DQ, IQ/OQ, PQ, PV
- Water for Injection, PW, Clean Steam, CIP
- Site Master File
- Establishment Licensing
- DIN Application
- CMC Support
- Medical Devices Licensing
- Clinical Trial Applications
- Pre-Approval Inspections
- Support during Regulatory Inspections & Annual Reviews
- Manufacturing Strategy
- Production Management
- Production Planning
- Technology Transfer
- Aseptic Processing, Formulation & Filling
- Protein Purification & Separation
- Production Optimization & Improvement
- Process Scale-up
- Upstream & Downstream Processing
- Clinical & Commercial Manufacturing
- Containment
- Cleanroom Management
- GMP/GDP/GCP Training
- BioProcess Training
- Batch Production Records
- Standard Operating Procedures
