CaseStudiesPresentation Final

Project Management Approach to Successful Outsourcing:Richman Chemical Case Studies

Presented by: Christopher Kulp Keith Crumley Brian Watsonwww.richmanchemical.com

Richman Chemical Inc.www.richmanchemical.comACS 2004Philadelphia, PA

IntroductionRCI is a premier company in outsourcing:Many years of process and project management experience Problem-solving focusKnowledgeable, flexibleAble to identify optimal manufacturing locations for your specific needs


Introduction (continued)Expertise working with numerous categories of customersVirtual Technology- Medical DevicePharmaceutical- NutritionalSpecialty Chemical- ElectronicAbility to assist with a wide range of outsourcing requirements (both large and small scale)Custom/Toll Manufacturing- Sourcing All compliance types- Logistics


Call the Sourcing Experts at RCI!

Customer: A Contract Manufacturer

Requirement: Needed scale-up of a hard-to-find pharmaceutical intermediateOriginal supplier was unable to produce the intermediate beyond R&D quantities


Call the Sourcing Experts at RCI! (continued)Solution: RCI was able to locate a European vendor through their extensive international network

Result: The project was a success! RCI procured the material, arranged importation, and facilitated customs clearance


A Business in Jeopardy!Customer: A desperate company

Requirement: In need of raw materialRegular international vendor unable to satisfy immediate / unexpected requirement due to time considerations inherent with importation


A Business in Jeopardy! (continued)Solution: RCI identified & contacted domestic manufacturerMaterial was procured and delivered on time

Result: A grateful customer who was able to maintain a positive relationship with THEIR client!


Expert Sourcing OpportunitiesCustomer: Diagnostic CompanyRCI customer back for more quality sourcing opportunities

Requirement: Product cost and inventory reduction initiative for several products supplied by other vendors


Expert Sourcing Opportunities (continued)Solution: RCI was able to:Import quality bulk material at reduced costArrange custom packaging per customers release quantityProvide warehousingEnsure timely releases at the customers request

Result: Materials were:Sourced- HousedPackaged- Delivered in a timely, cost-effective manner


Virtual Manufacturing Company Needs Complete Package

Customer: A virtual company

Requirement: Customer needed:Raw materials sourcedManufacturing StorageLogistics


Virtual Company Needs Expert Outsourcing! (continued)Solution: RCI set up all required aspects of the project:Sourcing of raw materials from outside the U.S.Drying and packaging of intermediateTransporting intermediate to secondary processing facility for agglomerationComplete logistics managementStorage and periodic release of final product

Result: Virtual company was able to produce product in a timely, cost effective way!One-stop shopping made project manageable


One Man Cannot Do It Alone!Customer: Medical doctor/independent researcher in need of full staffDoctor developing new drug candidate

Requirement: Customer in need of:Small scale custom synthesisProcess developmentDevelopment of protocolScale-up


One Man Cannot Do It Alone! (continued)Solution: RCI was able to:Provide all requirements utilizing a qualified custom synthesis laboratory within our manufacturing partner networkContract a larger facility for production

Result: The one-man team now had the resources and capabilities of a fully-staffed lab all within the budget of an independent researcher who had an idea which is now an important drug candidate


EMERGENCY! Need a Novel Chemical Excipient- STAT!

Customer: Medical device company targeting expansion into new market

Requirement: Needed a crucial (and hard-to-make!) excipient for clinical trial work Novel organic compound formulated with the actual medical device to provide the desired properties.BIG problem: the company had NO expertise in the synthesis of complex organic compounds.


EMERGENCY! Need a Novel Chemical Excipient- STAT!(continued)

Solution: RCI was able to:Optimize the synthetic process Scale it up to the appropriate manufacturing size Develop an FDA-approved, cGMP manufacturing protocol for successfully making the critical material All within a span of approximately 18 months.

Result: Satisfied customer and long term supply agreement


High Energy in Low SupplyCustomer: Major military contractorDevelops high performance propulsion materials for proprietary applications

Requirement: Needed highly explosive starting material for sensitive formulationUltra volatility of the substance necessitated the skills of highly trained chemists


High Energy in Low Supply (continued)Solution: RCI maintained a close relationship with a custom manufacturing site having a strong background in highly energetic chemistry

Result: The job was done:Quickly - At a low cost Safely- Efficiently


A Problem Needed Solv-ingCustomer: Large chemical company who used a highly purified solvent for in-house testing protocols

Requirement: Needed large quantities of purified solvent IMMEDIATELYCurrent supplier cancelled deliveries and discontinued processNo technology was provided


A Problem Needed Solv-ing(continued)Solution: RCI was able to:Identify a new purification process that workedSet-up regular manufacturing at a local facility Contribute in developing an alternate processCoordinate shipments for the yearEstablish a long term supply agreement

Result: The chemical company was able to continue the supply of purified solvent to its customers at the right price


Biotech Firm turns VirtualCustomer: Start-up Biotech companyRe-invented itself as a virtual firmHas no laboratory, pilot, or manufacturing facilities

Requirement: New virtual company needed cGMP facility for scale-up of crucial intermediate


Biotech Firm turns Virtual(continued)Solution: RCI provided:Management for the production of the intermediate at a cost-effective cGMP facilityFDA-related advice concerning intermediate production

Result: Successful productionOn time deliveryReady-to-use cGMP facility at their disposal for future clinical trial and commercial requirements.


Special Thanks to:

Andrea PlackeProject Management AssistantSummer 2004 Intern(University of Delaware)

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