Pharmaceuticals
Generic, hybrid and innovator products across national, DCP, MRP and centralised routes.
Industries
Industries We Support
Built around your product. Designed for your market.
Biotechnology
Biologics and biosimilars: comparability strategy, BLA/MAA planning and agency engagement.
APIs
DMF, ASMF and CEP authoring, maintenance and customer-facing regulatory support.
CDMO / CMO
Site variations, CMC documentation and regulatory support packages for client filings.
Medical Devices
EU MDR, UKCA and FDA routes, technical documentation and post-market obligations.
IVD
IVDR classification, performance evaluation and technical documentation strategy.
Diagnostics & Health-tech
Classification, borderline determination and software-related regulatory questions.
Start-ups
Regulatory roadmaps, feasibility and investor-facing due diligence support.
Case Studies
Representative Engagements
Anonymised engagement summaries. We do not publish client names, numerical success claims or approval guarantees.
Client challenge
Generic pharmaceutical manufacturer
Multi-country registration strategy sequencing EU DCP with GCC and African submissions from a single core dossier.
Client challenge
Medical device manufacturer
EU MDR technical documentation gap assessment against GSPR, clinical evaluation and PMS requirements.
Client challenge
API manufacturer
DMF/ASMF restructuring and customer-facing regulatory support for downstream filings.
Client challenge
Biotech company
Global regulatory pathway assessment comparing US, EU and APAC development obligations.