the flexpro group - project management for the life sciences - 2015

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We work with progressive Life Sciences companies to ensure key projects thrive. Our clients range from early start-ups to Fortune 100 companies. For more informaon on engaging our services, visit our website: www.theflexprogroup.com 484-674-7838 x101 info@theflexprogroup.com Looking for Project Management experse to tackle key projects? A culture of flexibility aracts people who go above and beyond to get the job done. Our people are the reason our clients keep coming back. Seasoned Life Sciences experts All FlexPro project managers have the relevant industry experience to hit the ground running. Most have 10 years or more. Mulple cerficaons and areas of experse Many of our project managers have advanced degrees, PMP certification, and Six Sigma training. Flexibility leads to success Our culture of flexibility keeps our PMs happy and motivated – and your projects on schedule and on budget. People who understand your industry… and people Our project managers bring proven processes and extensive experience to the table. And they have people skills to keep everyone working together. Inc 500 Fastest Growing Private Companies: 2012, 2013 Inc 5000 Fastest Growing Private Companies: 2014 Rose Cook Awarded Smart CEO’s Philadelphia Brava! Award: 2014 Philadelphia 100 Fastest Growing Privately Held Companies: 2012, 2013 Project Management for the Life Sciences Flexibility at work. FlexPro specializes in delivering highly qualified Life Sciences project managers with the experience and skills to dive right in and keep your project running smoothly from start to finish. That’s flexibility at work.

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We work with progressive Life Sciences companies to ensure key projects thrive. Our clients range from early start-ups to Fortune 100 companies.

For more information on engaging our services, visit our website:

www.theflexprogroup.com 484-674-7838 [email protected]

Looking for Project Management expertise to tackle key projects? A culture of flexibility attracts people who go above and beyond to get the job done. Our people are the reason our clients keep coming back.

Seasoned Life Sciences experts All FlexPro project managers have the relevant industry experience to hit the ground running. Most have 10 years or more.

Multiple certifications and areas of expertise Many of our project managers have advanced degrees, PMP certification, and Six Sigma training.

Flexibility leads to success Our culture of flexibility keeps our PMs happy and motivated – and your projects on schedule and on budget.

People who understand your industry… and people Our project managers bring proven processes and extensive experience to the table. And they have people skills to keep everyone working together.

Inc 500 Fastest Growing Private Companies:2012, 2013

Inc 5000 Fastest Growing Private Companies: 2014

Rose Cook Awarded Smart CEO’s Philadelphia Brava! Award: 2014

Philadelphia 100 Fastest Growing Privately Held Companies: 2012, 2013

Project Management for the Life Sciences

Flexibility at work.FlexPro specializes in delivering highly

qualified Life Sciences project managers with the experience and skills to dive

right in and keep your project running smoothly from start to finish.

That’s flexibility at work.

When you have the strategy in place, but need help with implementation. FlexPro brings you process-focused leaders with the passion and expertise to spearhead your projects to success. Whether it’s pharma, biotech, or medical devices, our project management experts get your Life Sciences projects done.

New Drug DevelopmentNew Device DevelopmentNew IndicationsNew Delivery SystemsDrug/Device CombinationsNew Dosage Forms

Research & DevelopmentOur project managers are knowledgeable in the phases of product development from pre-clinical through commercialization. They understand the critical interface with Pre-Clinical, Clinical, Regulatory, Marketing, and Chemistry, Manufacturing & Controls (CMC) areas to achieve targets for developing new products.

Rx-to-OTC SwitchesRegulatory Agency FilingsClinical Trials (Phases I, II, and III)Regulatory Agency Review MeetingsDrug Labeling Development

New Product LaunchesLine ExtensionsReformulations or Product ImprovementsPackaging, Labeling, or Graphics UpdatesCost-Improvement InitiativesRegulatory-Mandated Process or Product ChangesManufacturing Site Qualification and TransfersTech Transfers

Supply Chain OperationsFrom planning to delivery, our project managers know supply chain. Our project managers bring best-practice expertise and processes to every aspect of your supply chain. They effectively manage their teams, stakeholders, and vendors in Technology, Engineering, Manufacturing, Packaging, Graphics, Procurement, Regulatory, Quality, Planning, Distribution, and Logistics, implementing your supply chain projects with precision, speed, and grace.

Qualification of New Ingredients, Components, and SuppliersQuality and Compliance InitiativesCustomer Service ImprovementSupply Chain Reliability Improvement and OptimizationCAPA (Corrective Actions / Preventative Actions) Management and ClosurePost-Audit Remediation ProjectsBrand Protection / Serialization

Project Management Office (PMO) Design and ImplementationProject Charter DevelopmentResponsibility Assignment (RACI) Matrix DevelopmentStage Gate Process and Governance Structure Development

Project Management SystemsOur project managers design and develop Project Management Systems to ensure your projects are on time and within budget. Our project managers don’t just understand project management system processes and tools – they know which ones work best for you. Enjoy working with a seasoned professional adept at implementing systems via new or established Project Management Offices (PMO’s), and know that your projects are in good hands.

Escalation Process DevelopmentRisk Assessment DevelopmentPortfolio Analysis and ManagementProject and Portfolio Management Software Implementation

For more information on engaging our services, visit our website: www.theflexprogroup.com or call 484-674-7838 x101