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Biopharmaceutical and Medical Device

WE PROVIDE
Business Operations, Due Diligence, Auditing, Quality Services, Regulatory Affairs, and Technology Transfer Support. 
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WE OFFER
Phase-appropriate Quality and Regulatory solutions to minimize on cost without sacrificing quality.
A man is working in a clean room in sterile cleanroom coveralls with hair net, mask and shoe covers. He is cleaning the laminar flow hood with sporicide and sterile IPA. Location is inside a cGMP cleanroom manufacturing suite.

We can draft SOPs, create a brand new Quality Program, and everything in between. Some of the services "in between" are: Interpreting regulatory requirements, implementing an eQMS, performing Risk Assessments, conducting Investigations (with advanced root cause analysis), establishing Quality Metrics, implementing Environmental Monitoring (EM) programs, executing internal audits  and other site inspection-readiness activities, developing and qualifying Analytical Methods & Specifications, as well as Reviewing & Implementing Change Management Controls & individual projects. 

Regulatory Affairs

This is one of our biggest areas of focus. We continue to help our clients with Document Preparation, Technical Writing, and Reviewing for FDA and Global Filings. We work through NDAs, INDs, ANDAs, and NADAs. We have provided assistance on Regulatory Filings & Strategies for years. We provide a variety of services related to CMC, including: CMC Development & Gap Analysis, Supplier & CDMO Management, and Technical Writing for Module 3. We are ready to help with any Regulatory Compliance issue.

ISO 9001 is the standard cGMP pharmaceutical manufacturers adhere to. ISO 9001 is a quality system management system that determines the standards for manufacturing of pharmaceutical drugs.

Technical Support

Our Technical Support services are broken up into three divisions: Validation Engineering, Scientific Assistance, and Technical Services. Consultant experience executing: Equipment Validation, Process Validation, eQMS Implementation and Validation, CSV (21 CFR Part 11 Compliant), Technology Transfers, Process Simulations, Engineering Batch Oversight, Media Fill Qualifications, Environmental Monitoring Program Implementation and Validation, Program/System Assessment, Develop & Optimize Laboratory Controls & Analytical Methods, Investigations, Process Optimization, and Process Evaluation & Design.

Drug Delivery Systems

Over the past decade, we have been at the forefront of advanced drug delivery system commercialization. We have worked with all of the major vendors, CDMOs, and innovators related to LNPs & other lipid-based nanocarriers. We have the experience of taking a Pre-Clinical drug product to market. We work to develop non-GMP and cGMP Processes to deliver mRNA, DNA, and other APIs to targeted sites and tissues. We have the ability to develop your Analytical Methods, establish your Stability Program, and manage your Clinical and Commercial Supply Chain. With over 35 LNP Technology Transfers completed to date, we are happy to help you at any point in the product lifecycle. 

DNA, RNA, mRNA, siRNA are the active pharmaceutical ingredient in gene therapy drug products. Gene therapy drug products are made of lipids, liposome, polymers, polymersomes or nanoparticles.

Operations and Manufacturing

We have the Manufacturing and Product Development expertise to get your drug to market in the most expeditious way possible. We rely on our network of CDMOs, CROs, and Supply Chain Management staff to oversee your Clinical Supply. Current projects also include: Project Management, Supply Chain & Procurement, Business Process Management, and Sales & Marketing. We are ready to start by planning the execution of your next Technology Transfer or take a look at your current processes with a fresh perspective and LEAN approach. 

Auditing

A second pair of eyes to review and evaluate your systems and processes is always a good idea. We can provide this service in-person or virtually. Since the pandemic, we have increased our offerings of virtual audits and documentation reviews. Now that there are vaccines and effective protocols, we have hit the road again and are ready to evaluate your Supply Chain. We can get you fit by performing Facility Inspections for cGMP-readiness, Due Diligence, and Gap Assessments.

Operations and manufacturing of cGMP grade pharmaceutical drug products is a service provided by Aust Business Solutions. We provide project management, supply chain and procurement, business process management and sales and marketing services.
Aust Business Solutions provides training, curriculums and procedures for investigations, root cause analysis, CAPAs, change orders, change management and deviations.

Training

We provide Training that is customized to your company's specific needs. We can tailor any of our programs to use data, historical trends, and examples from your company, as well as others in the industry, to provide a tremendous value to your team. We can create and provide Training, Curriculums, and Procedures in the following areas: Investigations, Root Cause Analysis, & CAPAs, Change Management, Supply Chain Management, Project Management, Technology Transfers, Aseptic Technic, cGMP & FDA Guidance, Quality Control, and G&A.

Facilities Design

By utilizing the talent of Industry Leading Experts, Specialized Contractors, and our Partners & Sister Companies, we are able to build you the Laboratory, Manufacturing, and Administrative spaces required to operate most effectively. This includes developing and enhancing existing drawings for HVAC, water, and sterilization systems. Current projects include: developing flows of materials, equipment, & personnel, Designing facility per client requirements, establishing laboratory operations, and performing audits during construction & installation. 

Quality Systems