A multinational pharmaceutical company initiated a development partnership with a small US start-up to advance a portfolio of Class III medical devices based on a novel biomaterial.
As project manager for two years, I led a diverse, international team of experts and executives. Together we defined a project plan, design and development plan, design input, and initial ISO 14971 risk analysis.
We successfully conducted pre-clinical proof-of-concept studies, performed a gap analysis of manufacturing processes, and developed optimized formulations for further testing. Throughout the collaboration, I provided regular progress reports to the management board.
I am the Expert by your Side
True success is built on clear goals and consistent execution, not on toughness or noise.
Turning Expertise into Actionable Insights
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- Aesthetic dermatology
- Medicinal plants & herbal medicines
- Biomaterials
- Medical devices
- Ophthalmology & orthopedics
- Reviewing non-clinical chapters for EU MDR documentation
- Preparing technical & scientific due diligence
Concept
Insight: Developing innovative products such as substance-based medical devices, combination products, or herbal medicines is complex. Technical and regulatory hurdles can slow down or block progress, especially when in-house expertise or resources are limited. To move forward, projects need clarity on feasibility, a structured development strategy, and solutions to overcome regulatory and technical challenges.
From Idea to Strategy
Transforming complex product concepts into clear, feasible development paths.
Practical Solutions
Challenging ideas, addressing hurdles, and defining workable ways forward.
Leadership & Collaboration
Building effective teams, connecting stakeholders, and integrating expertise.
Scientific Expertise
Specialized knowledge in herbal medicines, dermatology, biostimulators, and biopolymers.
Proven Track Record
more than 23 years of Pharma & MedTech R&D experience, combining leadership and academic excellence
Case Study I: Leading an International R&D Collaboration
Case Study II: Preparing for Technical & Scientific Due Diligence
A medium-sized European biomaterials company was entering negotiations with a larger international partner. Engaged as an expert in biomaterials and aesthetic dermatology, I reviewed the existing data and reports, performed a gap analysis, and advised on how to best present the information. I also recommended additional studies to strengthen the scientific package. My input provided the client’s business development team with a clear, credible foundation for discussions with the potential partner.
Case Study III: Achieving MDR Compliance for a Substance-Based Device
A medium-sized European company faced the risk of reclassification or loss of CE certification for a substance-based medical device under Regulation (EU) 2017/745 (MDR).
Consulted as an expert in medicinal plants, I collaborated with the client’s analytical team to investigate the composition and pharmacological activity of the herbal extract. I engaged with contract labs on suitable proof-of-concept studies and explored alternative preparation methods to meet regulatory requirements.
These insights equipped the project leader with a clear basis to plan the product’s MDR compliance strategy.
References
Dr. Michael Pfeil
VP Nonclinical Developement, former Site Head
“I had the opportunity to work with Charlotte on a highly challenging process transfer project from R&D to manufacturing. Charlotte proved profound knowledge of the scientific and technical background as well as collaborative and solution focused leadership skills. She is an expert in the field of hyaluronic acid-based hydrogels and an absolutely reliable partner for complex tasks who is able to keep a team motivated throughout the project.”
Stephen Makin, PhD
VP Consumer Health R&D, Visiting Professor at King’s College London
„[…]Dr. Reither established an extremely good relationship with her direct reports, peers and managers. She set clear directions for the group and rapidly established the priorities for the business […].
„[…]Dr. Reither established an extremely good relationship with her direct reports, peers and managers. She set clear directions for the group and rapidly established the priorities for the business […].
Dr. Andreas Rose
Senior Quality Manager
„Zusammen haben wir an diversen Projekten gearbeitet: – Sicherstellung der GMP Compliance im Entwicklungslabor – Erstellung einer Prozesslandkarte inkl. RACI-Matrix für Entwicklungsprojekte – Erstellung von SOPs/WIs im Bereich Design and Development von Medizinprodukten – Inspektionsvorbereitung , -durchführung und -nachbereitung Die Zusammenarbeit mit Charlotte war jederzeit sehr kollegial und von großer Wertschätzung sowie gegenseitigem Vertrauen geprägt.“
„Zusammen haben wir an diversen Projekten gearbeitet: – Sicherstellung der GMP Compliance im Entwicklungslabor – Erstellung einer Prozesslandkarte inkl. RACI-Matrix für Entwicklungsprojekte – Erstellung von SOPs/WIs im Bereich Design and Development von Medizinprodukten – Inspektionsvorbereitung , -durchführung und -nachbereitung Die Zusammenarbeit mit Charlotte war jederzeit sehr kollegial und von großer Wertschätzung sowie gegenseitigem Vertrauen geprägt.“
Dr. med. Rolf Bartsch
Plastic Surgeon
“Charlotte has a deep understanding of the science behind dermal fillers. It was a pleasure to work with her on highly innovative early development projects as well as product launches.”
“Charlotte has a deep understanding of the science behind dermal fillers. It was a pleasure to work with her on highly innovative early development projects as well as product launches.”
Micki Lew
Senior Director, Global Regulatory Affairs
“Charlotte is a creative leader with strong technical background. I have worked with her on Class III medical devices for the US market including discussions with the FDA on non-clinical strategies that led to product approvals. Her thoughtful insight and solution-oriented approach focused the team on moving projects forward in a collaborative manner.”
“Charlotte is a creative leader with strong technical background. I have worked with her on Class III medical devices for the US market including discussions with the FDA on non-clinical strategies that led to product approvals. Her thoughtful insight and solution-oriented approach focused the team on moving projects forward in a collaborative manner.”
David Ferrero, PhD
VP Portfolio and Project Management Early Development
“…Charlotte is independent, detail-oriented, and deeply knowledgeable about the medical aesthetics market. A strong presenter and collaborator, she excels at driving projects forward, connecting the dots, and ensuring seamless execution. Her ability to align teams and deliver results makes her a tremendous asset to any organization. I highly recommend her for any role requiring strong leadership, project execution, and cross-functional collaboration.”
Dr. Alejandro Lopez Landa
RA/QA Consultant
“…Her organizational and technical skills and commitment to her projects are remarkable, making her ideal for complex Life Science projects.
Charlotte´s proactive attitude and problem-solving abilities make her someone you can always rely on. She manages resources, schedules, and team dynamics with efficiency and grace and her dedication to delivering high-quality results is truly inspiring.”
Cheri Mao
Head of Aesthetics Strategic Program Lead
“Charlotte is everything one looks for in a partner and program manager. Her confidence and competence are rooted by her depth of experience. She is thoughtful, data-driven, solution-oriented, pragmatic, and open to alternative viewpoints. Aside from Charlotte’s professional qualifications, she is a warm person who truly wants to bring joy to her work and her colleagues. A rare gem.”
Dr. Elsa Locardi
Head of R&D Project Management
“…Her program management skills are exceptional and her knowledge in new product development and injectable aesthetics field is very thorough. I really enjoyed working with Charlotte since she has always delivered on the tasks assigned to her, with clear communication and building strong relationships within the teams…”
Approach
My consulting approach is structured, transparent, and results-oriented. Each phase builds on the previous one and concludes with a clear deliverable such as a written report, project plan, or presentation.
Phase I – Orientation
Review data
Identify gaps
Define next steps
Identify gaps
Define next steps
Phase II – Planning
Strategy & Structure
Project & time plans
Regulatory strategy
Collaboration partners
Project & time plans
Regulatory strategy
Collaboration partners
Phase III – Execution
Leadership & Delivery
Interim management
Drive work packages
Meet milestones
Interim management
Drive work packages
Meet milestones
Phase IV – Transfer & Maintenance
Sustain & Support
Knowledge transfer
Training & coaching
Ongoing advisory
Knowledge transfer
Training & coaching
Ongoing advisory
01.
Phase I – Orientation
- Building a solid foundation by analyzing the current situation and identifying priorities.
- Reviewing existing data and information Identifying key topics and gaps
- Connecting with stakeholders, teams, and experts
- Conducting literature research
- Defining recommendations and next steps
Typical duration: 2 days to 3 months (approx. 16–200 hours)
02.
Phase II – Planning
- Translating insights into structured strategies and actionable plans.
- Developing project and time plans
- Refining key topics and recommendations
- Identifying collaboration partners
- Defining development and regulatory strategies
Typical duration: 1 week to 3 months (approx. 30–420 hours)
03.
Phase III – Execution
- Driving projects forward with leadership and focus.
- Leading as interim manager or project leader
- Executing work packages according to project plan
- Managing timelines and milestones
Typical duration: several months to 1 year or more, depending on complexity.
04.
Phase IV – Transfer & Maintenance
- Ensuring continuity and long-term success
- Knowledge and technical transfer
- Training and coaching
- Supporting teams and processes
- Providing ongoing scientific and technical advice
Duration depends on project scope and needs
About me
I am the Expert by Your Side, bringing strong leadership and collaborative focus to guide complex life science projects forward with clarity and purpose.
Let’s make progress happen.
Expertise, clarity, and collaboration — exactly when you need it.
Get in touch – I am the Expert by Your Side