Novo Compliance R&D Feasibility
The importance of regulatory compliance and a systematic risk management approach in early stages of the product lifecycle can’t be overstated. Teams responsible for R&D usually lack a practical understanding of the level and detail of regulatory compliance needed to ensure the intended market entry and position and therefore business success.
Many large manufacturers & enterprises rely on an elaborate database implementation to record regulatory compliance and risk management activities, but the inputs must come from individuals and these usually end up being quality engineers who move into R&D teams within a matrix organisation and act as data entry and record keeping specialists who can operate the management software and know how to fill in the forms. With such arrangements, most companies attempt to manage and bypass the inherent tensions that exist between risk/quality management and creativity.
We can use turn tension into a driving force to fuel the development and foster innovation. We have decades of experience in R&D, risk management and regulatory compliance within a clinical collaboration setting. We enable developers to think like risk managers and clinicians at the same time and document their work like quality managers while generating innovative solutions.
Because of many years clinical experience in understanding how the patient and clinical needs are combined with regulatory requirements and translated into technical specifications we have in one place the skills and knowhow that are normally the functions of different parts of the organisation and only come together at large cross functional meetings between R&D, QARA, Human Factors, Clinical operations, Marketing, etc.
The way we prefer to work is not to engage in firefighting, even though we can do that very effectively and efficiently. Instead, we prefer to work with you and members of your team at various stages of the product’s lifecycle to be able to add value to your work and avoid negative feedback from the regulators and/or the market in later stages.
We have several engagement models that reduce our cost to you well below our competitors whilst enhance our effectiveness exponentially.
Faq's
Strategic Importance of Early Compliance
Regulatory compliance and systematic risk management are foundational to successful market entry and long-term product viability. Yet, R&D teams often lack practical insight into the depth and specificity of compliance required—jeopardizing both positioning and business outcomes.
Common Organizational Dynamics & execution Pitfalls
Many large enterprises deploy sophisticated compliance databases, but the quality of inputs depends on individuals—often quality engineers embedded within R&D. These professionals become de facto record-keepers, navigating software systems and documentation protocols. This setup attempts to reconcile the inherent tension between creativity and regulatory rigor but often suppresses innovation rather than enabling it.
Turning Tension into Innovation
We believe this tension can be transformed into a catalyst for innovation. With decades of experience in R&D, clinical collaboration, and regulatory strategy, we empower developers to:
- Think like risk managers and clinicians.
- Document like quality professionals.
- Innovate with confidence and compliance
Integrated Expertise Across Functions
Our clinical experience enables us to translate patient and clinical needs into technical specifications that meet regulatory expectations. We unify capabilities typically scattered across:
- R&D
- QARA
- Human Factors
- Clinical Operations
- Marketing
This convergence eliminates silos and accelerates alignment—without waiting for cross-functional summits.
Proactive Lifecycle Engagement
Rather than firefighting late-stage issues, we embed ourselves throughout the product lifecycle to:
- Add strategic value at every stage
- Prevent regulatory setbacks
- Anticipate market feedback
Flexible, Cost-Effective Engagement Models
Our engagement models are designed to:
- Dramatically reduce costs compared to competitors.
- Exponentially increase effectiveness.
- Adapt to your team’s structure and needs.
Executive Summary
Bridging Innovation and Compliance in Life Sciences Product Development
In the early stages of the product lifecycle, regulatory compliance and systematic risk management are critical to market success. Yet, R&D teams often lack practical insight into the depth of compliance required, leading to costly delays or misalignment with regulatory expectations.
Large enterprises typically rely on complex databases to track compliance activities. However, these systems depend on individuals, often quality engineers embedded in R&D, who serve as record-keepers rather than strategic contributors. This structure attempts to reconcile the tension between creativity and regulatory rigor but often stifles innovation.
We transform this tension into a catalyst for innovation. With decades of experience in R&D, clinical collaboration, and regulatory strategy, we empower developers to think like clinicians and risk managers while documenting like quality professionals. Our integrated approach combines technical, clinical, and regulatory expertise normally siloed across departments into a unified framework that accelerates development and ensures compliance.
Rather than firefighting late-stage issues, we engage proactively across the product lifecycle to add strategic value, prevent regulatory setbacks, and anticipate market feedback. Our flexible engagement models deliver exponential effectiveness at a fraction of the cost of traditional consulting, making us a high-impact partner for life sciences innovators.
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