Our Offerings
Launch Excellence
Ensuring a Seamless Transition from Approval to Market Success.
At AZB Consulting, we provide comprehensive support to pharmaceutical companies during the critical phase of product launch.
Our services are designed to ensure compliance, operational readiness, and strategic alignment, facilitating a successful market entry.
Our comprehensive approach addresses the multifaceted challenges of launching a new drug, providing strategic and operational support tailored to each client’s needs.
Our Expertise
Our Launch Excellence Services Include:
Compliance with Healthcare Professionals
We provide guidance to ensure that all interactions with healthcare professionals comply with national regulations, transparency obligations (Sunshine Acts), and ethical promotional practices. We help align activities with the standards outlined by the EFPIA Code of Practice and local regulations (such as French Transparency Law (Loi Bertrand) in France, ABPI code for Discosure in the UK…)
Local Requirements
We support you in each step of the local requirements : BlueBox advice/submission when needed, National code application, Serialization declaration to EMVO & NMVO, compendium declaration, launch notification, Educational materials submission to local health authorities, Declaration of local responsible person, provision of local PV qualified person…
Quality System and Audit
We support the establishment and auditing of quality management systems to ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements.
Our team prepares companies for inspections and implements corrective and preventive action plans (CAPAs) when needed.
Specific case of France : Exploitant Status
We guide companies through obtaining « Exploitant » status required to market medicinal products in France. This includes setting up the necessary organizational structure and ensuring appointment of a Responsible Pharmacist (Pharmacien Responsable) in line with the French Public Health Code.
Launch Readiness & Strategy
We design tailored launch readiness plans that integrate regulatory preparedness, market access, supply chain coordination, and cross-functional stakeholder engagement. This ensures a smooth and timely product launch across target markets.
Promotional Material Review & Sign-Off
We offer regulatory advice on local requirements, regulatory and medical review and validation of promotional/non-promotional materials. We support you to develop your global and local compliance SOPs and training materials. We provide you with the local responsible person as required (Information Officer in Germany, Pharmacien responsable in France, Medical signatory in Spain, ABPI signatory in the UK,…)
Our team ensures that all promotional content complies with applicable laws and codes such as EFPIA Code of Practice at EU level or local codes such as including submission to the ANSM (Agence Nationale de Sécurité du Médicament) for prior validation where necessary. ANSM – Promotional Materials Requirements in France. We support you in all EU countries as required.