 |
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|
PROJECT NAME |
SERVICES |
PROJECT DETAIL |
|
Strategy /
Consult |
Business
Case |
Transact
Facility |
| "Latina" |
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Consolidate nine manufacturing facilities into five. The project was a result of a merger. Latina represented a significant investment and sites included Brazil, Columbia, Mexico, Dominican Republic and Venezuela. |
| Sterile Manufacturing Facility |
|
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Identify and acquire a sterile manufacturing facility in North America. |
| Bulk Active Pilot Plant & Product Launch Facility |
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Create technical marketing package (critical utilities, equipment list, validation documents, etc.) and cytotoxic-oriented database to support targeted marketing strategy. Support site visits and assist in negotiating the transaction of a bulk active facility. |
| R&D Consolidation |
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Create technical marketing package (critical utilities, equipment list, validation documents, etc.) and R&D-oriented database to support target marketing strategy. Support site visits and negotiate sale of facility. |
| "Fig" |
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Develop regulatory, facilities and manufacturing due diligence assessment for four US facilities as a result of merger. |
| Sale / Lease |
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Develop regulatory and facility due diligence for acquisition of R&D facility. Support lease costs for newly renovated R&D facility. |
| Technology Transfer |
|
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Develop tax-advantaged manufacturing options for high-end antibiotic product and implement technology transfer as a result of a merger. |
| Acquisition of R&D Processing Labs |
|
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Acquire a new R&D process lab for US operations. API and heavy solvent usage - critical issues. |
| Negotiate Lease |
|
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Find and negotiate lease for pilot / lab for recent merger spin-off. |
| Manufacturing Acquisition |
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Identify companies needing a solids manufacturing facility in NC; support acquisition costs benchmarked for 450,000 SF acquisition on 12/31/02. |
| Consolidation |
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Manage the shutdown of 350,000 SF facility in Europe including database of equipment / material, master shutdown plan, management of resources, vendors, manufacturing. |
| Biologics R&D Laboratory Acquisition |
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Complete site selection study, identify available R&D facility, negotiate lease and start-up new biologics joint venture. |
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PROJECT NAME
|
SERVICES
|
PROJECT DETAIL
|
|
Strategy /
Consult
|
Business
Case
|
Transact
Facility
|
| Acquire R&D facility for solids |
|
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Identify for purchase or lease a new research facility with pilot scale development capacity. |
| Acquire R&D site |
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Biotech company needs larger research facility; possible manufacturing as well. |
| Acquire GLP Research facility, pilot-scale development, cGMP |
|
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Facility must be expandable to accommodate an expansion into clinical supplies business. |
| Acquire Parenteral facility for new cancer product |
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Illuminate market for suitable available facilities. |
| Acquire manufacturing and packaging facility |
|
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Acquire cGMP manufacturing and packaging facility to support consolidation. |
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PROJECT NAME
|
SERVICES
|
PROJECT DETAIL
|
|
Strategy /
Consult
|
Business
Case
|
Transact
Facility
|
| R&D site |
|
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Identify for purchase or lease a new research facility with pilot scale development capacity. |
| R&D site |
|
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Market R&D manufacturing site in Kansas City. |
| 40,000 Ampoule business as ongoing concern |
|
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Major European Pharmaceutical transacting business in Europe. |
|
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PROJECT NAME
|
SERVICES
|
PROJECT DETAIL
|
|
Strategy /
Concept
|
Implement
|
| Production Packaging |
|
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Relocate medical device production packaging. |
| Research Lab Equipment and Development Equipment |
|
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Relocate Chemical / Pharmaceutical R&D lab equipment. |
| Heavy Industrial (Rubber dies and molds) |
|
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Medical device production facility. |
| Chemical / Pharmaceutical |
|
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Relocate powders, granulations and liquid production. |
| Biopharmaceutical |
|
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Relocate liquid fermentation. |
| Biopharmaceutical |
|
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Relocate powders, granulations and liquid development. |
| Pharmaceutical |
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Relocate medical device production. |
| Pharmaceutical |
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Relocate packaging. |
| Pharmaceutical |
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Relocate analytical LAN. |
| Pharmaceutical |
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Liquid / bead manufacturing consolidation. |
| Computer Data Center |
|
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Relocate center. |
|
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PROJECT NAME
|
SERVICES
|
PROJECT DETAIL
|
|
Strategy /
Consult
|
Business
Case
|
Implement /
Build
|
| Confidential |
|
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Develop outsourcing options for Biologic and Parenteral Fill / Finish in North America and Europe for new biological products. |
| Confidential |
|
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Develop outsourcing options for Biologic and Parenteral Fill / Finish in North America, Asia and Europe for new Cytotoxic product. |
| Potent Product Launch Facility |
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Develop Business Case for Potent Product Launch Facility. |
| Life Sciences Strategy |
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Develop competitive Life Sciences Strategy for tax-advantaged manufacturing. |
| Technology Transfer |
|
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Develop tax-advantaged manufacturing options for high-end antibiotic product and implement technology transfer. |
| Medical Device |
|
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Develop insourcing options for sophisticated wound closure innovation, including strategy for facility acquisition and fit-out. |
| Finished Dosage Form Pricing Benchmark |
|
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Develop benchmark of 6 major dosage forms through benchmark of major
pharma / biotech companies. |
| Life Sciences Strategy |
|
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Develop business case / legislation support for state government deriving to enhance biotechnology. |
|
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PROJECT NAME
|
SERVICES
|
PROJECT DETAIL
|
|
Strategy /
Consult
|
Business
Case
|
Implement /
Build
|
| R&D Property Closure & Transfer, >250 labs |
|
|
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Provide onsite management and technical team to identify hazards, perform sampling and survey, dispose of wastes and debris, and decontaminate facility. |
| Cytotoxic R&D Lab Decommissioning |
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Provide onsite project managment for cleaning, decommissioning, equipment removal and waste disposal. |
| R&D Lab Closure & Lease Transfer |
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Develop and execute a survey plan in accordance with NUREG 5849 to obtain NRC release prior to property transfer. |
| Wastewater & Air Quality Compliance |
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Obtain permits, design capital improvement and oversee construction / start-up of a comprehensive wastewater and air quality control system. |
| Manufacturing Facility Re-Use Assessment |
|
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Investigate and assess residual levels of penicillin and cephalosporin to determine level of decontamination required and potential for reuse. |
| Biotech R&D Closure / Documentation |
|
|
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Review, assess and document owner-performed decommissioning of an R&D facility. |
| Environmental Permitting & Clean-up |
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Design, install and permit a wastewater treatment system, remediate solvent spill. |
| Decontaminate & Decommission a Facility |
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Develop a hazardous material inventory, sample residual materials, & develop and implement an Environmental, Health & Safety Demolition Plan. |
| Comprehensive Environmental Services |
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Conduct facility-wide environmental audits, remove and replace underground storage tanks, design and install groundwater cleanup system. |
| Due Diligence Audits & Assessments |
|
|
|
IES has implemented over 150 due diligence audits & environmental site assessments, often with responsibility for executing required corrective actions. |
| Environmental Audit |
|
|
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Develop and implement a comprehensive multi-plant assessment of environmental permits and practices and recommend improvements. |
| Property Re-Use Evaluation |
|
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Develop cost estimates for 3 re-use scenarios for a manufacturer of inorganic chemicals. |
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PharmaBioSource, Inc., 121 West Wayne Avenue, Wayne, PA 19087 • Phone: 610.293.0900 • Fax: 610.293.6907
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© Copyright 2009 PharmaBioSource, Inc. All rights reserved. Pharmaceutical equipment
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