To ensure clear communication from the beginning of every new sponsor relationship, summarized below is a description of the events and documents that are a part of our normal process. Each step of this process is critical to the timely and satisfactory completion of your work.

In order to protect the interests of all parties, a confidential disclosure agreement (CDA) is necessary. We have drafted a bilateral agreement that we believe covers all relevant issues surrounding confidentiality. If our clients prefer to use their own standard agreement, we certainly understand. However, in those instances we ask that our unilateral agreement be signed, which protects Magellan Laboratories' intellectual property. Once each party's legal departments have approved and executed the CDA(s), formal project discussions and site visits may proceed.

Magellan Laboratories strongly encourages a visit to its facility by all potential sponsors. The visit is designed to give an overview of our standard operating procedures, capabilities, operations, and facilities. Another key component of the on-site visit is the introduction of essential staff members that may be involved with your projects. These preliminary discussions are useful in evaluating your needs. Analytical test methods, stability protocols, and any other relevant background information can also be delivered and discussed at this time. A Quality Assurance audit can be performed during this visit or can be scheduled separately.

Once a project has been defined via either telephone conversations or a site visit, a price quotation will be initiated. This document establishes the foundation for the business relationship between Magellan Laboratories and clients, and contains our Standard Terms and Conditions. The scope of the project is captured in as much detail as possible, so that all parties have a clear understanding of the proposed activities. Once the quotation is approved and signed, a test protocol can be initiated. It should be noted that while the price quotation is a critical element of the process, it is approval of the test protocol, and not the price quotation, that triggers initiation of testing or sample storage.

The test protocol is the compliance document that describes the project. Information such as the detailed scope of the project, sample descriptions, test methods and specifications or alert limits are fundamental components to the test protocol. The test protocol may look similar to the quotation, but the two should not be confused. The signature page of the test protocol contains more Magellan Laboratories signatures than the quotation, since it addresses regulatory compliance issues. Once a protocol is signed by the client, samples may be submitted for storage and analysis. Please note: work cannot begin until the test protocol is signed. This is the controlling document of all studies.

Any material submitted to Magellan must be accompanied by a material safety data sheet (MSDS). Ideally, the MSDS will arrive prior to the samples, so that it may be evaluated and any special conditions addressed. All samples should be sent to the attention of the sample coordinator (see below), and should be accompanied by a letter that gives all relevant background information, such as the lot number and statement of the intended project assignment. All reference material should arrive with a certificate of analysis to: