What we deliver
Scientific advice & agency meetings
Briefing book preparation and rehearsal support for EMA scientific advice, MHRA meetings and FDA interactions.
Impurity & genotoxicity control strategy
Control strategies for organic, inorganic and residual solvent impurities, including assessment and control of genotoxic (mutagenic) impurities.
Small molecule CMC & registration strategy
Development-phase regulatory roadmaps for APIs and finished dose forms, from quality target product profile through to the submission data package.
Biosimilar & generic development support
Stepwise comparability strategies, reference product selection, generic and hybrid pathway planning and agency interaction support.
BLA & NDA preparation (US)
Preparation of Biologics License Applications and New Drug Applications for the FDA, plus the post-approval changes, annual reports and commitments that keep a US authorisation current.
Comparability assessments
Analytical and functional comparability strategies for process changes, with justification packages for regulators.
Biologics development strategy
Regulatory roadmaps for monoclonal antibodies, fusion proteins and other biologics, covering quality, nonclinical and clinical requirements.
MAA preparation (EU & UK)
Planning, authoring and review of marketing authorisation applications for biological and small molecule products under the centralised and national procedures.
Tell us where your programme stands and where it needs to go. We'll outline how Minerva can help and propose next steps.
Biotechs advancing a first-in-human biologic
Pharma companies taking a small molecule from development into registration
Teams developing biosimilars, generics or hybrids for EU or US markets
Companies preparing EMA scientific advice or FDA Type B meetings
Programmes managing post-approval changes to biological or small molecule processes
Who we work with
Relevant expertise
Discuss your biologics programme
Monoclonal antibodies and recombinant proteins
Small molecule APIs and finished dose forms
Biosimilars, generics and hybrids (EU and US pathways)
ICH Q5A–Q5E and Q6B biologics guidelines
ICH Q1 stability, Q3 impurities, Q7 and Q11 API development, M7 genotoxic impurities
Cell substrate characterisation and viral safety
Analytical comparability and quality target product profiles
Centralised procedure and Article 3(2) referrals