Our Offerings

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.

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.

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.

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.

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.