Our Offerings
Drug Development Consulting
Accelerate your path to market with expert-driven development
At AZB Consulting, we combine deep regulatory intelligence with the proven expertise of our consultants to drive the success of your drug development programs. With extensive experience working with European Medicines Agency (EMA) and national regulatory authorities, we anticipate challenges and help you navigate the path to approval with confidence.
From early development through to commercialization, we offer end-to-end strategic and operational support tailored to your product and strategy. Our experts ensure your development aligns with evolving guidelines to build solid foundation for marketing authorization.
Whether entering Europe for the first time or expanding your footprint, we provide a clear, customized roadmap through EU regulatory and HTA pathways—helping you reach the market faster and more efficiently.
Our services include regulatory strategy, submission planning &, risk assessments, gap analyses and due diligence. We provide advice to ensure you’re always one step ahead of agency expectations.
Our Expertise
At AZB Consulting, we offer a comprehensive suite of regulatory services designed to accelerate drug development and ensure compliance at every stage.
Our team provides strategic, scientific, and operational support across key areas:
Regulatory Strategy & Roadmap
We develop tailored regulatory strategies and roadmaps aligned with your product lifecycle and business goals—guiding you efficiently from early development to market authorization. European Medicines Agency – Regulatory Strategy
Chemistry, Manufacturing and Controls (CMC) Solutions
We provide strategic CMC input and documentation support to ensure your manufacturing and quality data meet EU and global regulatory requirements. EMA – Quality Guidelines
Health Authority Meetings
We support you in planning and executing successful meetings with health authorities, helping craft compelling messages and anticipate key questions to maximize outcomes. This includes support for both EMA-level interactions and coordinated national advice through initiatives like Simultaneous National Scientific Advice (SNSA), which enables dialogue with multiple National Competent Authorities at once.
Orphan Drug Designation (ODD)
We offer full support for ODD submissions, including strategic positioning and preparation of robust justifications to enhance the likelihood of designation, the maintenance of our ODD and can support you for the similarity report. EMA – Orphan Designation Overview
EMA or EMA/HTA Scientific Advice
Our experts prepare high-quality briefing documents and guide you through the EMA or joint EMA/HTA scientific advice process to de-risk your development and align with stakeholder expectations. Our experts will support you to navigate in the new European Joint Scientific Consultations and European Joint Clinical Assessments procedures by preparing high-quality and timely deliverables.
Paediatric Investigation Plan (PIP)
We design PIP strategies that are scientifically sound, compliant, and aligned with your development timelines and global regulatory requirements. We prepare, submit and follow up the dossier through the procedure. We ensure that PIP compliance is done in a timely manner. EMA – Paediatric Investigation Plans
CTIS, Investigator’s Brochure (IB) and IMPD Writing
We deliver clear, compliant, and submission-ready Investigator’s Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs) to support EU and global clinical trial applications and support you to navigate in CTIS portal for your CTA submission. EMA – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
ASMF, DMF, and CEP Writing
We prepare high-quality Active Substance Master Files (ASMFs), Drug Master Files (DMFs), and Certificates of Suitability (CEPs) that meet regulatory expectations and integrate seamlessly into your development and submission strategies. For more information on ASMF procedures, refer to the EMA – Active Substance Master File Procedure. Details on DMFs can be found in the FDA – Guideline for Drug Master Files, and information on CEPs is available through the EDQM – Certification of Suitability.
Advanced Therapy Medicinal Products (ATMP)
We offer regulatory expertise tailored to gene, cell, and tissue-based therapies, helping you navigate the complexities of ATMP development and submission and support you for the ATMP classification. EMA – ATMP Overview
Gap Analysis & Due Diligence
Our comprehensive gap analyses and regulatory due diligence assessments help you identify potential risks, validate readiness, and make confident development or investment decisions. EMA – Pre-Authorisation Guidance
PRIME: Priority Medicines
We assist in securing eligibility for the European Medicines Agency’s (EMA) PRIME scheme, which offers early and enhanced support to expedite the development of medicines that address unmet medical needs.