Program & Project Management Services

Helping Pharmaceutical, Medical Device, and Biotechnology companies successfully deliver their complex projects.

Program & Project Management Services

We understand that you are constantly faced with complex projects with tight timelines, finding or freeing up resources to meet those deadlines, and are often dealing with trying to balance your daily work with yet another urgent initiative or critical pipeline project. 

ProPharma’s Program & Project Management offering provides the right resource or solution for the right project at the right time. Our project managers seamlessly join teams and successfully implement projects, drug development programs, and other transformational initiatives within pharmaceutical, biotech, medical devices, and diagnostics companies. Our practitioners share a winning approach that blends insights from their subject matter expertise, prior project successes/lessons learned, peer learnings, and fit-for-purpose project design. 

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Streamline Project Success with Expert Project & Program Management

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Successfully Complete Complex Projects

Our proven expertise in project management helps leaders like you prioritize effectively, ensuring your projects get done efficiently and on schedule.

Successfully Complete Complex Projects

Our proven expertise in project management helps leaders like you prioritize effectively, ensuring your projects get done efficiently and on schedule. Read Less
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Tackle Tight Timelines

We help leaders prioritize effectively, ensuring projects get done efficiently and on schedule.

Tackle Tight Timelines

We help leaders prioritize effectively, ensuring projects get done efficiently and on schedule.

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Alleviate Resource Burnout

We remove the burden on your staff, allowing them to focus on their core responsibilities without being overwhelmed by project work.

Alleviate Resource Burnout

We remove the burden on your staff, allowing them to focus on their core responsibilities without being overwhelmed by project work. Read Less
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Eliminate Scope Creep

Say farewell to scope creep and incomplete projects with our strategic management approach that ensures projects reach completion without unnecessary delays.

Eliminate Scope Creep

Say farewell to scope creep and incomplete projects with our strategic management approach that ensures projects reach completion without unnecessary delays. Read Less
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Find Balance Across Daily Work and Critical Projects

We'll help you balance your daily work when urgent initiatives or critical pipeline projects arise

Find Balance Across Daily Work and Critical Projects

We'll help you balance your daily work when urgent initiatives or critical pipeline projects arise

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Improve Visibility Into Key Projects

Gain clarity and insight into your projects with our comprehensive project visibility solutions, empowering informed decision-making across your organization. 

Improve Visibility Into Key Projects

Gain clarity and insight into your projects with our comprehensive project visibility solutions, empowering informed decision-making across your organization. 

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What Makes ProPharma Different?

Most Pharmaceutical, Medical Device, and Biotech companies struggle to execute or complete complex projects. At ProPharma, our deeply experienced professionals partner with client leaders to get their projects done right and allow them to focus on what they do best.

ProPharma's professionals have 10+ years of life sciences project management experience and are a mix of former Big 4 consulting, life sciences organization, or legacy ProPharma and have built a strong project management skill set either from those experiences, industry certifications (e.g., PMP, Lean Six Sigma, Prosci, Agile), and/or advanced degrees (e.g., MBA, Ph.D., MS).  

We believe that you deserve project management leadership and expertise so that you can focus on your core job responsibilities. You ought to have better visibility among all projects so that you can eliminate stress, frustrations, and confusion across your organization. And you shouldn’t go it alone. 

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Healthcare professional writing on clipboard at a conference table

Our Project Managers Lead Your Projects to Success

We understand how overwhelming it is to keep a project on track with all of your other responsibilities, which is why we have helped hundreds of companies over the last 25 years achieve the results they’re looking for. Our certified professionals deliver projects or your behalf, we set-up and establish project management offices (PMOs) or we provide companies with the training, methodologies and tools they need to empower team members with great project management strategies that lead them to success.

With the help of our deeply experienced professionals you will:

  1. Get better visibility into your projects so that you can properly prioritize company resources to the most mission-critical projects.
  2. See your team chemistry and morale improve because projects start and end. And,
  3. Apply best practice project management methodologies across your entire organization.

Our certified professionals deliver projects or your behalf, we set-up and establish project management offices (PMOs) or we provide companies with the training, methodologies and tools they need to empower team members with great project management strategies that lead them to success.

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ProPharma has the Experience You Require

Our Project Managers are capable of effectively working across the life sciences verticals, but we have significant expertise in: 

 Even if your area is not listed above, we are confident that our professionals can support you given their deep and diverse career experiences. 

We Specialize in These Types of Challenges 

  • Build out of a new manufacturing facility 
  • Identifying and staffing a skilled project manager to support your project needs 
  • Assessing and optimizing your Project Management Office – PMO 
  • Providing Project Management Outsourcing support for your function or department 
  • Providing program management support for early- or late-stage drug development programs 
  • Providing project management support for pre-approval inspection readiness and regulatory filings 
  • Overseeing remediation efforts for device, diagnostic, or drug inspections and audits 
  • Driving regulatory readiness for new regional/local device, diagnostic, or drug regulations 
  • Driving project management activities for post-merger integrations
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ProPharma Offers the Project Management Services You Need 

To ensure success, we identify and staff a skilled project manager to support your project needs across pharmaceutical, devices, or combination projects. We support process optimization, organizational initiatives, and technical implementations. Below are examples of our P&PM service offerings:

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Drug Development Project Management

Drug Development Project Management

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Post-Merger Integration​

Post-Merger Integration​

Submissions

Regulatory Readiness

Regulatory Readiness

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Audits & Inspections PM Support

Audits & Inspections PM Support

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Process Optimization & Organizational Change Management​

Process Optimization & Organizational Change Management​

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Specialized PM Services

Specialized PM Services

Drug Development Project Management

We can provide program management support for your early or late-stage drug development programs. Our PMs have expertise in either or both stages of drug development and as requested, will have specialization in therapeutic/disease areas to successfully drive your drug development programs.

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Post-Merger Integration

We understand that when your organization makes a significant investment in acquiring a new organization, excellence of post-merger integration execution is critical. But, for a Quality Assurance (QA) organization, there is an added complexity as both legacy organizations must execute ongoing activities and remain in compliance. It is not sustainable nor is it advisable to have two actively ongoing quality systems, long-term. This places the acquiring company with the difficult task of maintaining compliance across both systems and addressing potentially unnecessary cost, process, technology, and organizational redundancies.

ProPharma is deeply skilled in not only Post-Merger Integration but also Quality Assurance processes and technology. The latter is an uncommon Project Management Institute (PMI) skill set and is extremely important in being able to effectively drive your A groups to the desired future state. Our methodology and expertise in executing these activities can complement or drive your integration activities so you can realize integration success.

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Regulatory Readiness

Drive regulatory readiness projects for new or updated regional/local device, diagnostic, or drug regulations. As we did for EU MDR, we set-up the PMO, identify and staff PM need, and partner with your organization to successful prepare you for the regulatory requirements. 

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Audits & Inspections

Our project managers oversee remediation efforts for device, diagnostic, or drug inspections and audits. These efforts typically have several activities which must occur within a specific timeframe. We can help support your goal to achieve compliance by providing a PM to plan, oversee, and execute the effort provide key client stakeholders aware of project progress.

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Process Optimization & Organizational Change Management

We understand that throughout the R&D lifecycle, you are faced with multiple challenges such as addressing a process that is not efficient, looking for productivity opportunities, or developing a brand new process. ProPharma’s process optimization approach is collaborative in that we work with you to understand and address your process challenges while using a methodology rooted in lean six sigma and other industry leading process optimization techniques. Our experts will help you optimize your processes at any point in the R&D and Commercialization lifecycle.

To ensure that the updated or new process or project is successful, we integrate OCM processes based on PROSCI methodology to ensure that change impacts have been identified, assessed, and included in the solution, the appropriate stakeholders are aligned, communications and training have been developed/rolled out, and the organization has been sufficiently trained on the change(s). These steps will help to ensure these changes are sustained, post-completion of the project activities.

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Specialized PM Services

We provide specialized Project Management services such as:

  • Project Management Outsourcing support for your function or department. We drive all aspects of the process from intake, staffing the PMs, providing ongoing updates of project progress, and assigning of the projects.
  • Project Recovery to save projects that need urgent, turn-around support and achieve desired project objectives.
  • PMO Diagnostic/Health Check in which we assess and optimize your Project Management Office or your suite of projects. Includes PMO software dentification, tools, and roll-out.
  • PM Training to upskill your internal resources executing projects.
  • PM Mentorship to partner with your internal Project Management resources to help guide and enhance their ability to successfully deliver projects.
  • Operational Excellence & Innovation to pursue those projects looking to optimize processes or pursue innovative, challenging projects.
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Custom Solutions for Complex Needs

Schedule a call with one of our experts today and tell us about what keeps you up at night. Why? Because you will continue to spend too much time, too much energy and too many resources on projects that never get done until you partner with someone who will get them done right. 

Program & Project Management Experts

  • Rob Turner Bio Photo

    Rob Turner

    Senior Vice President, R&D Life Sciences Consulting

  • Bram Lardee Bio Photo

    Bram Lardee

    Senior Director, Product LifeCycle Management

  • Kyle Nordstrom Bio Photo

    Kyle Nordstrom

    Vice President, Compliance & Quality Assurance

  • Simona Mills Bio Photo

    Simona Mills

    Director, Product Lifecycle Management

  • Bob Beall Bio Photo

    Bob Beall

    Vice President, Quality and Compliance

  • Deb Bartel Bio Photo

    Deb Bartel

    Vice President of Quality Assurance

Program & Project Management Articles

October 27, 2023

How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration

How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration

A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...

May 28, 2024

A Guide to Solving Complex Life Sciences Challenges

A Guide to Solving Complex Life Sciences Challenges

Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...

June 23, 2023

7 Reasons Projects Fail (And How to Ensure Success)

7 Reasons Projects Fail (And How to Ensure Success)

Leadership at drug and devices companies are continually overwhelmed with the constant balance of driving daily work, managing resources, and addressing unplanned emergencies. This balance is then...

Agile Use in Non-Software Project

This whitepaper from ProPharma discusses how leaders in the pharmaceutical and medical device industries can use Agile development methods on their non-software related projects. Learn more about...

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Program and Project Management Effectively Deliver a QMS Optimization Program

Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...

News & Insights

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

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ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow