Embedded Solutions

Connecting clients with a flexible hiring alternative at the asset and clinical trial levels.

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Flexible Alternative to Hiring

Bringing a new drug to market is a complex and challenging process that requires specialized scientific and project management expertise. From the initial study documents (e.g., IND, CTA, etc.) to the final submission documents (e.g., NDA, MAA, etc.), ProPharma has successfully helped over one thousand clients by providing advice, guidance, and scientific or project management support required to navigate the drug development process.

All Embedded Solutions

ProPharma’s Embedded Solutions group helps our clients at both the asset and clinical trial levels by focusing on strategic, high-level consulting opportunities, and implementing those solutions.

embedded solutions

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We understand the importance of time in the early development process. Embedded Solutions provides a flexible alternative to traditional hiring. ProPharma provides “just-in-time” consultants to ensure our clients can avoid multi-month lead times that typically accompany the hiring of an internal employee. We also help our clients minimize the long-term costs related to hiring full-time internal employees. ProPharma collaborates closely with our clients to understand their needs. This enables us to quickly engage and place the right consultant embedded directly into your client environment. Our goal is to deliver successful results efficiently and effectively. 

Asset Level

At the asset level, ProPharma helps our clients in three main areas:

Development Plans

ProPharma serves as a trusted partner for both Scientific and Program Management needs. We work closely with our clients to understand their specific requirements and deploy the necessary team of Scientific and Program Management experts needed to provide the services required. Our consulting services range from adjusting existing development plans to creating new plans based on specific client needs.

Our Drug Development Program Managers provide essential services to the drug development programs. Their expertise includes cross-functional planning, timeline management, resource management, cost management, issue management, and risk mitigation among others.

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Furthermore, our Embedded Solutions consultants offer the option of individual subject matter experts or a team of experts embedded within the client’s environment. A typical team might include the following consultants:

  • Program Management
  • Regulatory Strategy
  • CMC
  • Nonclinical
  • Clinical Design
  • Any other areas for program support

This team of experts will assist in answering questions, preparing board meetings, help you prepare for funding discussions, etc. We are your trusted partner for scientific and program management experts.

Program Management

Depending on client needs, there are scenarios in which a Program Manager is needed who can seamlessly integrate with your existing team. This positions them to effectively lead the development teams and navigate the complexities of the drug development process. Whether you have an early-stage asset or late-stage asset, we can provide the appropriate experts to meet your development needs.

We specialize in providing an array of professional consultants including:

  • Drug Development Program Managers
  • Regulatory Program Managers
  • CMC Program Managers
  • Clinical Project Managers
  • Among others

Our Program Managers’ expertise spans a wide range of therapeutic areas including cell and gene therapy, immuno-oncology, rare disease, CNS, and CRISPR, among many others. Our consultants are true experts within their respective fields, equipped to handle any challenge that may arise.

Scientific Experts

Embedded Solutions provides specialized scientific experts who can seamlessly integrate into your client teams, leveraging their experience, existing skill sets, and industry knowledge. This enables quick collaboration and promotes cohesiveness, leading to the efficient progression of the asset through the drug development process.

Our experts excel in identifying risks to the Development Plan and implementing appropriate measures to address them effectively. We can deploy:

  • Nonclinical Consultants
  • Bioanalytical Consultants
  • Toxicology Consultants
  • CMC Consultants
  • Among others
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Clinical Trial Level

At the clinical trial level, our services Offer the necessary flexibility to meet our clients’ specific needs. We specialize in various areas including:

  • Clinical Operations
  • Data Management
  • Biostatistics & Programming
  • Medical Writing
  • Clinical/Medical Oversight

ProPharma's Embedded Solutions team actively engages in high-level strategic consulting opportunities tailored to our clients' requirements. By deploying expert consultants, we provide an alternative to hiring full-time internal team members. This approach ensures immediate results without the constraints associated with hiring internal employees.

Embedded Solutions for All Stages

Choose Embedded Solutions for flexible alternatives to traditional hiring. With our "just-in-time" consultants, you can avoid long lead times and minimize long-term costs associated with hiring full-time employees.  Our dedicated team will work to understand your specific needs and promptly place the perfect consultant directly into your client environment. Take the first step today by reaching out to us!

News & Insights

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High-Quality Outcomes

August 7, 2025

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High...

Discover how ProPharma enhances collaboration and quality in drug development by expertly coordinating and communicating with multiple vendors for unified, high-quality outcomes.

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European Marketing Authorization Success: The Critical Role of Quality and Compl...

Achieve European market success with robust quality and compliance solutions, ensuring seamless market entry and long-term growth through expert QP support

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Pros and Cons of Working with a CRO

Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.

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July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study Simplifying Global MLR Review: Local Expertise at a Global Scale

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High-Quality Outcomes

August 7, 2025

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High...

Discover how ProPharma enhances collaboration and quality in drug development by expertly coordinating and communicating with multiple vendors for unified, high-quality outcomes.

European Marketing Authorization Success: The Critical Role of Quality and Compliance

August 4, 2025

European Marketing Authorization Success: The Critical Role of Quality and Compl...

Achieve European market success with robust quality and compliance solutions, ensuring seamless market entry and long-term growth through expert QP support

Pros and Cons of Working with a CRO

July 31, 2025

Pros and Cons of Working with a CRO

Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Simplifying Global MLR Review: Local Expertise at a Global Scale

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Previous Resource Arrow Next Resource Arrow
Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow