Pharmaceuticals and APIs
VCI can help you with:
- Process Validation
- Analytical Method Validation
- Drug Master Files
- Risk Management (ISO 14971)
- Compliance
- Training
VCI provides a full range of support. We can manage a whole project, we can supply resources to augment your existing talent, we can train your people to do it them selves, or any combination of all of these that fits your needs best. We can help you with:
21 CFR 211 Good Manufacturing Practices for Pharmaceutical manufacturers.
- GMP training. Please call us to have VCI conduct training on 21 CFR 211 that is specifically customized for your needs.
- GMP Consulting. Whether you need a quick answer to a short question or a whole project that needs support, call VCI for accurate answers at 734 274 4680 or email us at Ask VCI to find out how VCI can help you. We design batch records, lab reports, packaging reports, release stickers, and any other forms, stickers, and labels used in the manufacturing, packaging, processing, holding, and control of finished pharmaceuticals or APIs. We also write SOPs, develop raw material and product specifications, perform company and vendor audits, qualify analytical labs, and help you communicate effectively with FDA.
- VCI makes learning the GMP regulations easy. Writing your SOPs and training your personnel is harder. Next comes the excruciating part: Getting everyone to follow your SOPs. VCI can make that part...well, tolerable. And you save money. Positive ComplianceTM
Drug Development Support. Your regulatory and submission strategy should be an integral part of your drug development business plan. The speed with which you can get your product on the market and generating cash depends in large part on your submission and approval process. Let VCI's experienced consultants help you formulate your submission strategy. The venture capitalists are more likely to fund your company if they believe you have a realistic estimate of when they will get a return on their investment.
Technology transfer. How will you transfer your technology into manufacturing? FDA requires very specific and complete information to be included in your technology transfer package.
Quality Systems Design and Compliance Upgrade Projects. Do you want to develop a new market, or enter more heavily regulated market for an existing product? VCI can help you develop an SOP system that is compliant and yet easy to use.
Validation Master Plans, Equipment Qualification, and Process Validation.
