Novo Compliance’s Regulatory Compliance (RC) in Life Sciences
Novo Compliance proprietary Regulatory Strategic ARC® provides each of our clients bespoke synthesized regulatory strategies during early and late-stage product development, leveraging extensive regulatory knowledge, expertise and experiences spearheading responsive and timely advising, developing, frameworking1 and executing customized regulatory approaches supporting optimization of client’s pipeline commercialization and marketing activities.
Includes Novo Compliance’s Regulatory Strategic ARC® Frameworking and Methodologies
Regulatory Compliance (RC) in the life sciences sector, spanning pharmaceuticals, biotechnology, and medical devices essential for safeguarding public health, ensuring product efficacy, performance, innovation responsiveness in multiple regulatory, healthcare and home use ecosystems and maintaining trust a sponsor’s portfolio of products provide innovative Therapies. Life Science sponsors, healthcare practitioners and patients understand the requirements adhering to a complex set of laws, guidelines, and international standards established by global health authorities.
Faq's
Frameworking
Clarifying Complexities, Advancing Interdisciplinarity, Reproducibility, Sustainability and Continuous Innovations throughout client’s end to end lifecycle
In the life sciences, “frameworking” (or the process of developing and applying frameworks) develops essential and the fundamental architecture organizing complex biological, ecological, and health-related phenomena into structured, interpretable models.
Novo Compliance’s Frameworking Life Sciences
Proprietary application of conceptual, theoretical, or methodological structures including:
- Guided research design & development advancing comprehensive and complete verification and validation principles required in cGxP and QMSR ecosystems.
- Interpretive data analysis, modelling and synthesized regulatory strategies
- Integrate interdisciplinary knowledge architecture implementation in matrixed enterprises
- Translate discoveries into synthesized enterprise policies and procedures
Novo Compliance’s Frameworks
| Type | Purpose |
|---|---|
| Conceptual Frameworks | Define relationships between variables or concepts in a study |
| Theoretical Frameworks | Ground research in established theories (e.g.evolution systems biology) |
| Methodological Frameworks | Outline procedures for data collection analysis and validation |
| Implementation Frameworks | Guide the translation of research into clinical or policy settings |
Novo Compliance’s essential Frameworking process leading to positive outcomes for our client’s includes-
- Clarifies complexity: Life sciences often deal with multi-layered systems (e.g., ecosystems, genomes, health networks).
- Promotes interdisciplinarity: Frameworks help bridge biology, chemistry, medicine, and social sciences.
- Improves reproducibility: Structured approaches make research more transparent and replicable.
- Supports innovation: Frameworks can reveal gaps in knowledge and inspire new hypotheses.
Novo Compliance’s proprietary modules, bespoke execution and innovative refinement incorporating our Frameworking in Life Sciences-
Ensuring Novo Compliance’s frameworking effectiveness:
- Align with theory: Ensure the framework fits within a scientific paradigm or theoretical tradition.
- Use empirical grounding: Base frameworks on observed patterns or validated data.
- Iterate and adapt: Frameworks should evolve with new discoveries and technologies.
- Engage stakeholders: Especially in health sciences, involving practitioners and patients improves relevance.
Novo Compliance’s Core Compliance Areas-
- Clinical Trials – Must follow Good Clinical Practice (GCP) and ethical standards.
- Manufacturing – Requires adherence to Good Manufacturing Practice (GMP) to ensure product quality.
- Labeling & Advertising – Must be truthful, non-misleading, and approved by regulators.
- Post-Market Surveillance – Includes adverse event reporting and risk management.
- Cybersecurity – Increasingly vital for connected medical devices, with standards like ISO/IEC 27001 and FDA’s premarket guidance.
Novo Compliance’s commitment to our Sponsors, Healthcare Practitioners and Patients driven through our Mission, Vision and Purpose and most importantly why this matters-
- Advancing Patient Safety – Prevents harm and ensures therapeutic benefits across a Sponsors portfolio.
- Sustainable Market Access – Non-compliance may lead to product recalls, fines, market removals or injunctions in one or more jurisdictions Sponsors have market authorization.
- Continuous Innovation Advancement and Protections – Ensures adequate protections of Sponsors intellectual property, proprietary services and data integrity, security and availability during a products life cycle.
- Maintains and continues building a Sponsors Reputation & Trust – Continuously builds a Sponsor’s credibility with key stakeholders, healthcare practitioners, patients and patient advocacy groups and with the general public.
Novo Compliance’s Core Compliance Areas-
- Clinical Trials – Must follow Good Clinical Practice (GCP) and ethical standards.
- Manufacturing – Requires adherence to Good Manufacturing Practice (GMP) to ensure product quality.
- Labeling & Advertising – Must be truthful, non-misleading, and approved by regulators.
- Post-Market Surveillance – Includes adverse event reporting and risk management.
- Cybersecurity – Increasingly vital for connected medical devices, with standards like ISO/IEC 27001 and FDA’s premarket guidance.
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