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


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.
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.
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

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

September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

May 3, 2022
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

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...

August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...
News & Insights

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Sep 27, 2023 11:57:42 AM
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Sep 25, 2023 4:59:00 PM
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

October 14, 2021
Accelerate European Market Access with Compliant and Comprehensive MAA Submission
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

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Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements
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Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
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Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
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Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

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Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

September 28, 2023
How a Two-Part NDA Regulatory Strategy Resulted in Submission Success
Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

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How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

October 14, 2021
Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
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Increased Visibility for Senior Management with Custom PMO Design, Implementation
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October 14, 2021
Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days
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MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
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September 28, 2023
Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life
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May 19, 2022
Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective
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Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

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Understanding Clinical Trial Requirements for Medical Device Label Extensions
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

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What You Need to Know About Regulatory Programs for Expedited Approval
Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

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Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

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Outsourcing Medical Information Services: When to Consider a Dedicated Resource
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Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
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