A Practical Roadmap for Biotech Development
In summary
Taken together, these principles highlight a simple reality: successful entry into the clinic is shaped well before the first subject is dosed. Developers who address these questions early don’t just reach first-in-human; they arrive prepared, credible, and positioned to progress with confidence.
If you’re at this stage and want to sense-check your development strategy, QbD Group works with biotech teams to translate early decisions into regulatory-ready execution. From regulatory strategy and scientific advice to CMC, quality, clinical operations, and safety, our experts help build coherent, scalable pathways toward first-in-human and beyond.
Let’s talk about how we can support your team.
References
European Medicines Agency (EMA)Scientific Advice and Protocol AssistanceGuidance on early dialogue with regulators to optimise development plans and reduce regulatory uncertainty.
European Medicines Agency (EMA)PRIME: Priority MedicinesFramework supporting enhanced interaction and early engagement for medicines addressing unmet medical needs.
European Medicines Agency (EMA)Orphan Designation and IncentivesOverview of orphan designation criteria, protocol assistance, and regulatory incentives in the EU.
European Commission. DG SANTEClinical Trials Regulation (EU) No 536/2014Legal framework governing clinical trials in the EU, including harmonised assessment and the Clinical Trials Information System (CTIS).
European Medicines Agency (EMA)Clinical Trials Information System (CTIS)Practical guidance on submission, assessment, and transparency requirements under the Clinical Trials Regulation.
International Council for Harmonisation (ICH)ICH Q8(R2) – Pharmaceutical DevelopmentGuidance on systematic development approaches and understanding of product and process design.
International Council for Harmonisation (ICH)ICH Q9(R1) – Quality Risk ManagementFramework for identifying, evaluating, and controlling quality risks throughout the product lifecycle.
International Council for Harmonisation (ICH)ICH Q10 – Pharmaceutical Quality SystemModel for an effective quality system applicable across the product lifecycle.
International Council for Harmonisation (ICH)ICH Q11 – Development and Manufacture of Drug SubstancesGuidance on CMC development strategies and documentation expectations for regulatory submissions.
European Federation of Pharmaceutical Industries and Associations (EFPIA)Clinical Trials Regulation and EU Clinical Research CompetitivenessIndustry perspective on implementation challenges and strategic implications of CTR and CTIS.
European Innovation Council (EIC)EIC Accelerator ProgrammeFunding and investment support for high-risk, high-impact innovation, including biotech development and scale-up.
About the Author
PhD · Global Head Regulatory Affairs at QbD Group
Angeles has built her career at the crossroads of science and regulation. From academic research at CNB and CNIC to leadership roles in biotech and global consulting firms like Asphalion, Parexel, Pharmalex, and Scendea, she translates regulatory complexity into action. She has a strong track record of building and scaling teams, and is especially focused on the intersection of data, AI, and regulation to unlock faster healthcare innovation.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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