Teddz Regulatory | UK • EU • Africa
Expert Regulatory Strategy & Operations
Guiding Pharmaceutical & Biotech companies through complex MHRA, EMA, and African regulatory landscapes.
Specialist Expertise In: MHRA (UK) | EMA (Europe) | NAFDAC (Nigeria) | SAHPRA (South Africa)
Navigate Regulatory Complexity with Confidence
At TEDDZ, we are your embedded regulatory operations team. We handle the complexity of submissions and lifecycle management, so you can focus on the science. We provide end-to-end support across the entire product journey.
Pre-MAA Activities
Strategic advice, Orphan Drug Designation (ODD), Paediatric Plans (PIP), and Scientific Advice to build a solid foundation.
MAA Preparation & Submission
Meticulous dossier gap analysis, eCTD publishing, and seamless liaison with all regulatory authorities.
Post-Approval Lifecycle
Reliable management of variations, renewals, annual reassessments, and ongoing strategic support.
Your Partner ACrosss Key Markets
United Kingdom
Deep expertise in all MHRA regulatory processes, including post-Brexit guidance, ILAP, and national submission requirements.
European Union
Navigating the complexities of the EMA centralised procedure (CP), as well as national procedures (DCP, MRP) with competent authorities.
Africa
Specialist knowledge of key African agencies, including NAFDAC (Nigeria), SAHPRA (South Africa), and Kenya’s Pharmacy & Poisons Board.
Expertise You Can Trust
We combine deep specialist expertise with the agility of a dedicated team, ensuring you get senior-level attention at all times.
Our Latest Regulatory Insights
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API Documentation: Navigating the ASMF (Drug Master File) in EU/UK Submissions
API Documentation: Navigating the ASMF (formerly DMF) in EU/UK Submissions The Active Pharmaceutical Ingredient (API) is the heart of any medicinal product. Providing its quality documentation is mandatory, but for API manufacturers, protecting the proprietary ‘know-how’ (intellectual property) is paramount. This is where the Active Substance Master File (ASMF) comes in. Formerly known as the…
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Regulatory Insights | EMA | EU | MHRA | UK
Early Access: A Guide to Named Patient Sales, Compassionate Use & EAMS
A Guide to Early Access: Navigating Named Patient Sales, Compassionate Use & EAMS What happens when a promising medicine is approved in one country (like the US) but not yet in the UK or EU? For patients with high unmet needs, waiting is not always an option. This is where ‘early access’ pathways come in….
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EMA | EU | MHRA | Regulatory Insights | UK
Orphan Drug Designation: A Strategic Guide to the EMA & MHRA Pathways
Orphan Drug Designation: A Strategic Guide to the EU & UK Pathways For companies developing treatments for rare diseases, Orphan Drug Designation (ODD) is one of the most powerful strategic assets available. It’s not just a label; it’s a critical tool that unlocks significant financial and regulatory incentives. However, following Brexit, navigating the ODD landscape…
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Ready to Streamline Your Regulatory Journey?
Let TEDDZ Regulatory guide your regulatory strategy.
Contact us today to book your free, no-obligation 30-minute consultation to discuss your project.