Consulting Services
Delphi Analytical has provided consulting services to numerous small and large companies over the last ten years. Some of our areas of expertise are listed below:
Regulatory Compliance (CGMPs and QSRs)
- Quality Assurance Auditing
Description
Delphi Analytical uses its extensive knowledge of the FDA's Quality Systems Based approach to CGMP compliance to evaluate your Facilities & Equipment, Materials, Production, Packaging and Labeling, Quality and Laboratory Controls Systems. - Pre-Approval Inspection (PAI)
Preparation
Description
Delphi Analytical will review your application and raw data to insure their will be no surprises when the FDA shows up for your inspection. - Contractor Audits and Outsourcing
Management
Description
Managing outsourced resources can be one of your biggest challenges and greatest risks. Delphi Analytical's extensive experience in this area can insure "error free" relationships by assisting with contractor selection, contractor qualification, work flow definition and supervision communication plan creation, auditing and data review, and technology transfer plan creation and implementation. - Scientific and Compliance Review of
Data and Reports
Description
Delphi Analytical's consulting staff’s skill sets spans every aspect of the pharmaceutical and medical device industries. Some of the more time consuming tasks which lend them selves to outside support with which we can assist include: methods validation, notebook and raw data review, batch record review, annual report review and updates, technology transfer report review, process validation data and report review, review of DQ/IQ/OQ/PQ documentation, and assistance with LIMS and software. - Standard Operating Procedure (SOP)
Writing and Review
Description
Standard Operating Procedures (SOPs) which detail common policies, practices and procedures within an organization. SOPs make up an essential component to any CGMP operation and are required by 21 CFR 211. SOPs are difficult and time consuming to create, review and update. Delphi Analytical can help you manage the process and to create more user friendly documents using its patent pending document creation technology. - Consent Decree Prevention and
Corrective Action
Description
Consent Decrees (CDs) are voluntary legal agreements between a company and the FDA which delineates how the company will upgrade its efforts to comply with the CGMPs or QSRs. Delphi Analytical has years of experience working with companies who have already gotten in trouble with FDA but also those who have taken preventive action. To date we have worked with four companies under CD, two of which have successfully fulfilled all obligations to FDA which resulted in lifting of the Decrees.
Management Consulting
- Project Management
Description
Many organizations develop problems because they fail to properly plan their work and allocate their resources in an effect manner. By doing so, all tasks become priority and every project becomes urgent. This ultimately leads to failures and lack of compliance with CGMPs. We can assist you and teach you how to use project management to put you firmly in control of your work schedules. - Process Mapping and Improvement
Description
The vast majority of all problems or inefficiencies within organizations are "system problems". Specifically, the lack of clearly defined processes and systems to implement the processes are what lead to problems. Delphi Analytical Services, Inc. has gained a unique understanding and grasp of process review and improvement within the pharmaceutical and medical device industry and are uniquely qualified to assist clients analyze their organizational structures, define key processes, and determine what improvements can be made to move the organization forward. - Small Business Startup
Description
Entrepreneurship is a term which is frequently used in business but not sufficiently understood. If you are looking to start your own business and need some help, many of Delphi Analytical's staff have built their own successful businesses from scratch. We will help you avoid the pitfalls and improve your chances for success. - Executive Leadership Mentoring
Description
Delphi Analytical Services, Inc. has gained a unique understanding of pharmaceutical and medical device industry operations over the last several years during its work with companies who are under consent decrees. From these experiences we have seen many “best practices” as well as practices which should not be emulated. We have also seen that most successes are the result of good leadership failures are the result of poor leadership. We feel, therefore, that we are uniquely qualified to assist key managers in becoming exceptional leaders. We can also provide interim managers and supervisors as needed to help your company achieve the highest level of performance and regulatory compliance possible.