FDA Remediation Services:
Perform many analytical chemistry consulting projects for major pharmaceutical companies involving remediation/ PAI readiness/gap analysis efforts to help the company achieve FDA compliance. The projects involve writing method development reports and protocols/method validation reports and protocols/method transfer reports and protocols, and analytical methods. I am heavily involved in reviewing/rewriting/gap analysis/calculating method development results/ method validation/method transfer reports and protocols, methods, and data packages
WPBAD is not a traditional contract laboratory. We offer all the advantages of a traditional contract laboratory while almost completely eliminating the disadvantages. We perform analytical development, method development, method validation, remediation consuting, and analytical chemistry training at your company site on a contract basis. This offers tremendous advantages in reduced costs, speed of job completion, ease of compliance with your internal SOPs, and no necessity to audit the external laboatory. Using a contract laboratory to complement or replace the in-house laboratory can offer several advantages. However, one must be aware of potential problems. The decision to use a contract laboratory can be based on a perceived financial gain, which in many cases is justified. Problems are mainly technical issues regarding authenticity/defensibility of data.
Reduced Costs and Time
WPBAD is able to perform analytical development, method development, method validation, and analytical chemistry training at your company site at reduced costs to your company. We can do that for a number of reasons: low overhead, quicker development time because of the extensive experience/knowledge and work ethic of our analytical development scientist. Less time translates into savings in costs and development time.
Authenticity/Defensibility of Data
WPBAD performs the analytical development work at your site-under your SOPS, your data storage facilities/policies using agreed-upon protocols. Direct interactions allow course corrections (if required), faster data review, faster report/protocol generation - while using formats compatible with your own internal SOPs.
Contract laboratory/Company Interactions
Using a a typical contract research, it is next to impossible to interact with the contract lab scientists in real time, much less observe/modify the details which are so crucial to a project. It is difficult to overstate the waste and inefficiency associated with this old approach. WPBAD eliminates these problems by being on-site for face-to-face meetings and any necessary modifications that may be needed. WPBAD will always attempt to follow any agreed-upon protocols, but has the flexibility to make modification, if the project requires them and client/WPBAD agree.
You Will Know Whom Will Perform Your Project
When working with most contract laboratories it is difficult to determine whom will actually be performing the work. Depending on whom is assigned - you will see a great disparity in competence, speed, and accuracy of completing the project. The work will be performed by scientist and owner, Gregory McLaughlin.
Additional WPBAD Advantages
1) Analytical development and training is our primary business- not an after thought
2) In-house performed analytical development performed under contract by an external expert-third party provides additional credibility of test results to regulatory agencies
3)Committed to providing you with excellent customer service so you can focus on your core competencies