Generics
EU Generic Pharmaceutical Registration & Market Entry Services
Your Strategic Partner in Navigating the European Regulatory Pathways to Deliver High-Quality, Cost-Effective Generic Medicines to Patients.
The European generic medicines market represents a significant opportunity for manufacturers focused on providing affordable, high-quality healthcare solutions. However, gaining access requires navigating a complex and highly regulated landscape. From our strategic headquarters in Malta, Aequum provides a comprehensive suite of services designed to streamline every phase of the generic drug registration and commercialisation process in the EU.
Our team of seasoned regulatory affairs experts specializes in the nuances of European guidelines. We manage the entire lifecycle, from initial dossier preparation to post-market pharmacovigilance, ensuring your products meet the rigorous EU standards for quality, safety, and efficacy. We handle the regulatory burden, allowing you to focus on what you do best: manufacturing and innovation.
Our End-to-End Generics Services Include:
Complete Dossier Preparation in eCTD Format We meticulously prepare and compile your complete marketing authorisation application dossier in the required electronic Common Technical Document (eCTD) format. Our experts ensure that all modules are robust, fully compliant with EU guidelines, and structured for a smooth and efficient review process by regulatory authorities.
Bioequivalence Study Management & Regulatory Submissions Demonstrating bioequivalence is a critical step for generic approval. We provide expert oversight for your bioequivalence studies, from advising on study design and CRO selection to managing the data and integrating the results into a compelling regulatory submission. We ensure this crucial evidence is presented clearly and effectively.
Pharmacovigilance & Post-Market Compliance Your regulatory obligations continue long after market approval. We establish and manage comprehensive Risk Management Plans (RMPs) and pharmacovigilance systems to ensure ongoing compliance. Our post-market support guarantees that you meet all safety monitoring and reporting requirements mandated by the European Medicines Agency (EMA) and national authorities.
EU Regulatory Liaison & Submission Strategy We act as your direct liaison with EU regulatory bodies, managing all communication to ensure clarity and efficiency. Our team provides expert guidance on the optimal submission strategy, whether through the Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP), to achieve the fastest possible approvals across your target markets.
Partner with Aequum to accelerate your generic drug's journey from development to European patients. Let us be the regulatory cornerstone of your commercial success.