We review your core materials against EFPIA/IFPMA/ABPI referential and support you at local level for the validation and maintenance of your local materials with appropriate local sign off and submission to authorities when required. We create and update abbreviated product information (API) texts. We provide regulatory advice on local ethical codes on demand and support you for maintaining training materials and related SOPs.
Life Cycle Management
Sustaining Compliance and Value Throughout the Product’s Journey
At AZB Consulting, we partner with pharmaceutical companies to ensure their products remain compliant, relevant, and competitive throughout their lifecycle—from post-launch maintenance to mature market adaptation and eventual withdrawal.
Our lifecycle management solutions are designed to optimize the long-term performance of your products while maintaining regulatory alignment and minimizing risk.
Life Cycle Management
Sustaining Compliance and Value Throughout the Product’s Journey
At AZB Consulting, we partner with pharmaceutical companies to ensure their products remain compliant, relevant, and competitive throughout their lifecycle—from post-launch maintenance to mature market adaptation and eventual withdrawal.
Our lifecycle management solutions are designed to optimize the long-term performance of your products while maintaining regulatory alignment and minimizing risk.
Our Expertise
Our Lifecycle Management Services Include:
Regulatory Maintenance & Variation Management
We manage the core dossier maintenance of your products, including the preparation and submission of all types of regulatory variations (Type IA, IB, and II), notifications, referrals, post-authorisations commitments and renewals across EU/UK. Our team ensures timely submissions and approvals, maintaining the validity and accuracy of your marketing authorizations throughout the product’s lifecycle.
Labeling Strategy & Updates
We provide strategic and operational support for CCDS/SmPC/PIL & Labelling maintenance, ensuring alignment with evolving regulatory, safety, and scientific standards. Our experts coordinate labelling change management and corresponding translations, and handle notifications or approvals required in each market up to the physical implementation of the changes locally.
Product Lifecycle Planning
We develop and execute tailored lifecycle strategies including Marketing Authorization Holder (MAH) transfer, certificate of pharmaceutical products (CPP) applications, line extensions, reformulations, or label expansions to support your commercial objectives. We help you navigate scientific advice procedures, regulatory intelligence, and feasibility assessments. We provide seasoned Project Managers for planning, coordination and compliance to regulatory standards.
European Promotional Review Services
Sunset Clause & Product Discontinuation Support
We guide you through market-specific obligations related to product supply, notification timelines, and regulatory withdrawal processes—ensuring compliance and a smooth exit when products reach end of life.
Regulatory Intelligence & Impact Assessment
We continuously monitor evolving regulatory landscapes and assess their impact on your marketed portfolio. We manage local regulatory databases. Our proactive approach helps you stay ahead of change and manage compliance risks efficiently.