Ottillia Fernandes
Consultant Specialist
Ottillia Fernandes brings nine years of pharmaceutical quality assurance experience to TDP's client engagements, with a strong focus on GMP compliance, batch record review, and deviation and CAPA management across both clinical and commercial manufacturing environments. Her background spans biologics, chemotherapy, and broader pharmaceutical dosage forms, with particular expertise in aseptic processing and QP release support. Clients working with TDP benefit from a specialist who has operated at the detailed, technical level where quality decisions directly impact product safety and release timelines.
Ottillia has contributed to complex quality activities including documentation migration to electronic document management systems, and has supported the demonstration of these systems to US FDA auditors during regulatory inspections. She works effectively across functions, collaborating with manufacturing, regulatory affairs, QC, and supply chain teams to ensure quality is embedded throughout the product lifecycle rather than applied as an afterthought.
What motivates Ottillia is knowing that the work she does through TDP has a direct impact on patient safety. Every batch record reviewed and every deviation resolved is a contribution to ensuring that medicines are safe, effective, and consistently delivered to standard. That sense of purpose is evident in everything she brings to a client engagement, and it reflects the commitment to quality that sits at the core of TDP's work.
Latest Work
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Expanding into new markets without a dedicated regulatory affairs team is the reality for many pharma companies. Here is how to build and manage a global submission programme that holds up under agency scrutiny — from pathway strategy and dossier architecture to post-submission management.
Scale-up failures don't just delay manufacturing. They delay regulatory approval. Learn how proactive MS&T input protects your programme and strengthens your CMC package.
Most regulatory submission delays trace back to CMC. Understand the most common gaps, why they happen, and how to prevent them before your filing reaches the agency.
Need specialist CMC expertise but cannot justify permanent headcount? Learn how outsourced CMC models give growing pharmaceutical companies the capability they need, at the stages they need it most.
Outsourcing regulatory affairs is not always the right call. But for many pharma businesses, it is. Here is how to know when the case stacks up
No quality team? No problem. Learn how scaling pharma companies build compliant, investor-ready quality functions without permanent headcount. Practical guidance from TDP.
No in-house audit team? Learn how to structure compliant GxP audit coverage using outsourced and retained models. Practical guidance for pharmaceutical and biotech organisations.
TDP's key takeaways from Making & Distributing Pharma 2026. What the MHRA said about AI governance, Annex 22, decentralised medicines, and the landmark transparency
Need a fast regulatory answer without starting a full project? TDP's Just Ask service gives you direct access to senior expertise within 24-48 hours. Find out how.
Received an inspection finding from the MHRA or FDA? Learn how to triage, structure a credible CAPA response, and protect your programme timeline. Expert guidance from TDP.
Total Delivery Pharma (TDP) announces a collaboration with Doc Check AI to explore AI-driven automation for GMP/GDP documentation and compliant document workflows.
Inside the TDP logo: a modern pharmacy “+”, an arterial droplet, and authoritative typography designed to signal GMP/GDP rigour and end-to-end delivery.
UK and EU healthcare regulations are diverging post-Brexit, requiring companies to navigate two evolving systems while maintaining compliance across both.
What GDP means in practice, why MHRA inspects it, where findings happen, and how to stay inspection-ready under a WDA(H).
Learn what a Responsible Person (RP) is, when you need one, what they do under GDP, how they differ from an RPi/QP, and how to appoint the right RP.
Learn what a Qualified Person (QP) does, when one is required, and how QP certification works under EU & UK GMP. Practical guidance from TDP.