Adhering to FDA regulations can be a very complex and daily concern for biotechnology, pharmaceutical, immunotherapy, food, beverage, dairy, medical device companies and healthcare professionals. At Bioinspection we assist companies with the right cGMP expertise.
Today's plant is a myriad of automated and manual process control hardware and software. Optimization in the plant is one of the most demanding tasks of all. Especially if it is to be achieved without costly modifications/down time of key systems. This is precisely where the focus of our team comes in. We can help you drive plant-wide optimization across multiple enterprises.
- Pre-approval audits and preparations, supplier quality audits, due diligence, routine or for-cause cGMP audits in manufacturing and/or quality departments of biotechnology and Pharmaceutical manufacturers.
- World-Class supplier auditing- Review the supplier function, execute the audit, prepare the report, and complete turn key services to track observations applicable to each supplier.
- Evaluation, qualification of cost effective suppliers.
- Consulting on contracts and negotiations.
- Packaging and shipping validation.
- Consulting on optimum procurement strategies.
Manufacturing Strategic Support:
- Commercial manufacturing strategies & options.
- Process and plant design.
- Modular, disposable manufacturing plants.
- Immunotherapy expertise.
Capital Projects & Infrastucture:
- Strategic facilities planning.
- Site selection.
- Commissioning & validation management and exeution.
- Facilities design.
- Process design.
Bioinspection helps you accurately and efficiently gain full supply chain visibility. Increasingly complex food supply chains make traceability an equally complex challenge. Our experts can establish the traceability of food products and ingredients starting from the farm to the plant. We look at all the challenges and all the issues to enable fast and efficient tracebility. We look at incoming inspection, record keeping and procedures, risk analysis, and product handling.
With complexity of today's food supply chains, it is increasingly difficult to manage supplier information, approvals and chain of identity. We help efficiently maintain supplier databases to ensure the supply of safe products, from manufacturing to wholesale, storage and distribution, and retail delivery paying close attention to the cold chain.
We will look at the entire operation and process flow. From incoming, manufacturing, labeling, packaging, utilities, outgoing distribution, security, and cold chain operations.