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Project Management
PharmaBioSource advocates a team approach to the planning and execution of successful projects. We use proven management techniques in order to accomplish the objectives of projects of a significant magnitude.
- Clear work assignments, deliverables, and target dates
- Daily direction / supervision of the detailed work involved
- Periodic assessment and reporting of progress
- Formal business / systems issue resolution
- Frequent communication among the project team and additional project participants
Business Case Development
PharmaBioSource will lead a company through an exploration of its capacity options to the development of a board level presentation with the objective of seeking approval of a chosen option. We will then work with a company in exploring one or several of the options listed below and will proceed to develop a case which supports a chosen option based on an assessment of the data acquired during the exploration phase.
- Launching a new product
- Options for acquiring / disposition of a facility
- Options for acquiring / disposition of an on-going concern
- Options for partnership
- Assessing impact of technology
- Other pharmaceutical consolidation considerations
Benchmarking
Benchmarking is often used in the exploration of capacity options and supports the development of the business case. PharmaBioSource has conducted national and international assessments of bulk biologic, fill / finish, cytotoxic, cephalosporin and parenteral facilities. PharmaBioSource has a database of transactions in the US and Europe that may be used to justify a position or confirm an acquisition price.
Technology Transfer
PharmaBioSource is proficient in developing protocols and managing the process for transferring experimental data, samples, machinery, manufacturing procedures and registration information. Technology Transfer requires experience and expertise in the following areas:
- Understanding which products will be transferred, terminated and sold
- Communication with a company’s various departments: Operations, QA / QC, Health / Safety Personnel, Marketing and Regulatory Affairs
- Methods of transfer ranging from Federal Express to railroad car to secure refrigerated van
- Consulting with Regulatory Agencies and internal procedures in order to properly deal with the following:
| Controlled substances |
Facility access database audit trail |
Test results |
| Hazardous Materials |
Validation Protocols / Documentation |
Correspondence with vendors |
| Paper / Microfiche, Records / SOP's |
Training documentation / HR |
Handling procedures for receiving units |
| Machinery / Equipment |
Material Safety Data Sheets |
Assay results and back-up |
| Frozen samples |
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Acquisition Due Diligence
PharmaBioSource has experience and due diligence methods that serve as guidelines for collecting and organizing information to be submitted for review by an acquiring company. The methods include protocols and categories that are specific to the pharmaceutical industry and the regulatory agencies.
PharmaBioSource has the disciplines to support various levels of due diligence activity and can build a team specific to a company’s needs.
IT Record Retention
A critical and delicate component of any facility consolidation / disposition plan, IT record retention involves the securing, keeping confidential, archiving and transferring of a company’s data.
Challenges that need to be met include:
- Supporting technology transfer of products
- Constructing an IT and Communications shutdown team
- Ensuring network and communications availability through the period of change
- “Cleaning” operating systems and data files
- Off-site archiving of essential files
- Inventory equipment and software
- Salvaging and transferring valuable remaining hardware and software
- Transfer of software licenses
Capacity Management / Supply Chain Consulting
PharmaBioSource can illuminate opportunities to acquire or shed capacity in an effort to increase supply chain efficiency.
- Financial performance review
- Benchmarking / Best-in-class performance
- Time-to-market strategy
- Cycle time study
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PharmaBioSource, Inc., 121 West Wayne Avenue, Wayne, PA 19087 • Phone: 610.293.0900 • Fax: 610.293.6907 |
© Copyright 2009 PharmaBioSource, Inc. All rights reserved. Technology transfer |
