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

From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidence

July 27, 2026

From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidenc...

Discover how ProPharma streamlines clinical trial study start-up, ensuring predictable activation and reducing risks from feasibility to first patient in.cl

QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Regulation

July 23, 2026

QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Re...

The FDA's transition to the QMSR simplifies compliance, emphasizing risk management and aligning with global standards for medical devices compared to QMR.

Building Relationships with Sites: The Hidden Driver of Faster Start-Ups

July 20, 2026

Building Relationships with Sites: The Hidden Driver of Faster Start-Ups

Discover effective strategies for building relationships with clinical trial sites to streamline the study start-up process and enhance activation timelines.

ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development

July 8, 2026

ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability fo...

ProPharma unveils an AI-assisted capability to enhance ANDA submission development, improving efficiency and maintaining regulatory excellence for clients.

ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and HTA Capabilities

June 18, 2026

ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and H...

ProPharma welcomes Kevin van Dooren as Vice President, HEOR and Market Access, strengthening integrated EU regulatory, HTA, reimbursement, and market access capabilities for life sciences companies.

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

May 27, 2026

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

ProPharma announces Adrian Pencak as Chief Commercial Officer, bringing 25 years of leadership experience to enhance global commercial capabilities and client partnerships.

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 Inspection-Ready AI: Building Quality Frameworks That Keep Pace with Innovation - ProPharma

July 23, 2026

Inspection-Ready AI: Building Quality Frameworks That Keep Pace with Innovation

As artificial intelligence becomes increasingly embedded across life sciences, organizations face a growing challenge: ensuring quality and compliance frameworks evolve alongside rapidly advancing...

Case Study Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A Regulatory and Pharmacovigilance-Led Solution - ProPharma

July 15, 2026

Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A...

Product shortages involving essential medicines can create significant clinical and regulatory challenges, particularly when vulnerable patient populations depend on uninterrupted access to...

Case Study Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sensitive Research - ProPharma

June 17, 2026

Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sen...

Conducting clinical research for rare pediatric populations presents unique operational challenges, particularly when eligible patients may be born anywhere in the world and require immediate...

From Feasibility to First Patient In: How to Streamline Study Start-Up  

September 30, 2026

From Feasibility to First Patient In: How to Streamline Study Start-Up  

Clinical trial delays often begin long before study conduct, with critical decisions made during feasibility and study start-up shaping the success of the entire trial. Join this webinar to discover...

Tech Meets Touch: Evaluating Empathy and AI in Medical Information Delivery

June 4, 2026

Tech Meets Touch: Evaluating Empathy and AI in Medical Information Delivery

Artificial intelligence (AI) is a hot topic in Medical Information (MI), yet real-world evidence of its impact in regulated, human-led MI environments remains limited. Hear practical, evidence-based...

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

News & Insights

From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidence

July 27, 2026

From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidenc...

Discover how ProPharma streamlines clinical trial study start-up, ensuring predictable activation and reducing risks from feasibility to first patient in.cl

QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Regulation

July 23, 2026

QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Re...

The FDA's transition to the QMSR simplifies compliance, emphasizing risk management and aligning with global standards for medical devices compared to QMR.

Building Relationships with Sites: The Hidden Driver of Faster Start-Ups

July 20, 2026

Building Relationships with Sites: The Hidden Driver of Faster Start-Ups

Discover effective strategies for building relationships with clinical trial sites to streamline the study start-up process and enhance activation timelines.

Previous Post Arrow Next Post Arrow
ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development

July 8, 2026

ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability fo...

ProPharma unveils an AI-assisted capability to enhance ANDA submission development, improving efficiency and maintaining regulatory excellence for clients.

ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and HTA Capabilities

June 18, 2026

ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and H...

ProPharma welcomes Kevin van Dooren as Vice President, HEOR and Market Access, strengthening integrated EU regulatory, HTA, reimbursement, and market access capabilities for life sciences companies.

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

May 27, 2026

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

ProPharma announces Adrian Pencak as Chief Commercial Officer, bringing 25 years of leadership experience to enhance global commercial capabilities and client partnerships.

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 Inspection-Ready AI: Building Quality Frameworks That Keep Pace with Innovation - ProPharma

July 23, 2026

Inspection-Ready AI: Building Quality Frameworks That Keep Pace with Innovation

As artificial intelligence becomes increasingly embedded across life sciences, organizations face a growing challenge: ensuring quality and compliance frameworks evolve alongside rapidly advancing...

Case Study Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A Regulatory and Pharmacovigilance-Led Solution - ProPharma

July 15, 2026

Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A...

Product shortages involving essential medicines can create significant clinical and regulatory challenges, particularly when vulnerable patient populations depend on uninterrupted access to...

Case Study Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sensitive Research - ProPharma

June 17, 2026

Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sen...

Conducting clinical research for rare pediatric populations presents unique operational challenges, particularly when eligible patients may be born anywhere in the world and require immediate...

Previous Resource Arrow Next Resource Arrow
From Feasibility to First Patient In: How to Streamline Study Start-Up  

September 30, 2026

From Feasibility to First Patient In: How to Streamline Study Start-Up  

Clinical trial delays often begin long before study conduct, with critical decisions made during feasibility and study start-up shaping the success of the entire trial. Join this webinar to discover...

Tech Meets Touch: Evaluating Empathy and AI in Medical Information Delivery

June 4, 2026

Tech Meets Touch: Evaluating Empathy and AI in Medical Information Delivery

Artificial intelligence (AI) is a hot topic in Medical Information (MI), yet real-world evidence of its impact in regulated, human-led MI environments remains limited. Hear practical, evidence-based...

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

Previous Webinar Arrow Next Webinar Arrow