Obtaining a Health Product License: Requirements and Regulatory Steps
Technical and Document Preparation Obtaining a prior operating license for medical devices does not start simply by submitting an application. It begins with thorough technical and organizational preparation. The health authority evaluates whether the company has the necessary structure, resources, and systems to ensure product compliance throughout all stages of its lifecycle. This includes internal […]
Qualipharma strengthens its leadership in Regulatory Affairs with the acquisition of Mic & Pharma
Qualipharma announces the acquisition of Mic & Pharma, a strategic operation that marks a milestone in its growth and consolidation within the pharmaceutical sector. With this integration, the company strengthens its Regulatory Affairs department, positioning itself as a reference company in the national market with a clear international outlook. Mic & Pharma brings a solid […]
Health Product License as a Regulatory Requirement in Spain
The First Regulatory Check Before a medical device reaches the market, there is a first regulatory check that determines all subsequent activities. The prior operating license allows companies to manufacture, import, or handle medical devices in Spain and establishes the beginning of their relationship with the health authority. This is not merely a formal permit: […]
Key Aspects of the New Era of PQR Following the Draft Revision of Chapter 1 of the NCF
Did you know that Chapter 1 of the NCF is currently under review? While the pharmaceutical regulatory framework is sufficiently specific, there are still technical details to address, as highlighted in the public consultation open until December of this year for Chapter 1 of the NCF. In recent years, we have seen regulations increasingly adopt […]
Legacy Lines and Annex 1: Time for Review and Redesign
More than three years have passed since the entry into force of Annex 1 of the GMPs, and, as expected, the timelines for implementing some of the required changes have not always met the demands of such a stringent regulatory framework. It is worth highlighting the efforts made by sterile product manufacturers, who have undertaken […]
From design to control: a new integrated standard for pharmaceutical quality
Six Phases. One Comprehensive Approach. The pharmaceutical industry is facing unprecedented challenges: growing regulatory complexity, tighter timelines, and increasing pressure to guarantee quality and compliance at every step. In this context, fragmentation between development, validation, and production often results in inefficiencies and risks. To address these challenges, Qualipharma and PTM Consulting are proud to announce a strategic collaboration. More […]
New changes in the regulation of human medicinal products
The European Commission has launched the draft Delegated Regulation (EU) 2024/1701, amending Regulation (EC) No 1234/2008 with regard to modifications of marketing authorisations (MAs) for human medicines (Regulation on variations) within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC. Transition period and objectives of the new regulation Although the first draft […]
The 5 Major Enemies of a Regulatory Dossier
Preparing and submitting a regulatory dossier remains one of the most critical yet vulnerable processes in the pharmaceutical industry. The pressure to meet deadlines, ensure quality, and avoid rejections from regulatory agencies like AEMPS, EMA, or FDA can be overwhelming. Despite technological advancements, many teams still face obstacles that compromise the efficiency and accuracy of […]
Pharmaceutical Registrations: When the Procedure Becomes the Greatest Risk
In the pharmaceutical industry, the preparation and management of registration dossiers continue to be one of the greatest operational challenges for technical and regulatory teams. Despite a high level of regulatory compliance and increasing technical complexity, many processes are still approached using traditional methodologies and limited tools. This turns the procedure into an operational burden […]