Regulatory and access to the HEALTH MARKET
Regulatory and Market Access for Medical Devices in Spain
Lentisco understands the particularities of the process for medical devices to reach the Spanish market. We know that these products, ranging from medical devices to diagnostic equipment, require a specific approach to comply with regulations and achieve successful commercialization. Our team of experts provides comprehensive support, covering all phases of the regulatory and market access process.
Regulatory Services for Medical Devices
Medical devices must comply with regulations that guarantee their safety and efficacy before being marketed in Spain. In Lentisco we offer:
Integrated bid management
We handle all aspects of the bidding process, from the identification of opportunities to the submission of bids. This encompasses the preparation of documents, compliance with legal and technical requirements, and the formulation of bidding strategies.
Regulatory strategy for medical devices
We develop strategies adapted to the specific regulations of the Spanish Agency of Medicines and Health Products (AEMPS) and European regulations, facilitating a clear and effective approval process.
CE marking and conformity assessment
We advise on the CE marking process, which includes the conformity assessment necessary to demonstrate that products comply with the essential safety and performance requirements established by European legislation.
Registrations and notifications at the AEMPS
We manage the notification and registration of medical devices with the AEMPS, ensuring that all legal requirements are covered, from product classification to the submission of technical documentation.
Post-Marketing Support
We provide continuous monitoring to manage incidents, documentation updates and maintain regulatory compliance throughout the product lifecycle.
Access to the medical devices market
Successful access to the medical device market depends not only on regulatory compliance, but also on an effective commercialization strategy. At Lentisco, we provide:
Market analysis for medical devices
We conduct specific studies of the medical devices market to identify opportunities for entry and expansion, considering the characteristics of the sector and demand.
Pricing and distribution channel strategies
We advise on pricing and on the definition of distribution strategies that maximize the penetration of the product in the Spanish market, adapted to the particularities of medical devices.
Launch and promotion
We develop launch plans and marketing strategies aimed at ensuring product visibility and adoption in the market, including dialogue with hospitals, clinics and other key points.
Collaboration with healthcare institutions and professionals
We facilitate contact with healthcare institutions and professionals in the sector to guarantee effective access based on the trust of end users.
Regulatory services for drugs
The marketing of medicines in Spain is subject to a rigorous regulatory framework that guarantees the safety, efficacy and quality of pharmaceutical products. At Lentisco, we offer a comprehensive service that accompanies companies at every stage of the process, from regulatory approval to market access, ensuring that drugs reach patients safely and effectively.
Regulatory services for drugs
The drug approval process in Spain is complex and requires strict compliance with current regulations. Our services include:
Regulatory strategy for medicines
We develop regulatory strategies that are aligned with the guidelines of the Spanish Agency for Medicines and Health Products (AEMPS) and European regulations to facilitate marketing authorization.
Development of the regulatory dossier
We advise on the preparation and presentation of the dossier required for marketing authorization, ensuring that it complies with the required scientific and technical standards.
Drug registrations and licenses
We manage the registration of medicines with the AEMPS, including the obtaining of marketing licenses and the management of decentralized or centralized procedures.
Post-Authorization and Surveillance
We provide ongoing support for variation, renewal and pharmacovigilance management, ensuring regulatory compliance throughout the drug lifecycle.
Access to the drug market
To ensure that medicines effectively reach patients in Spain, a solid market access strategy is necessary. At Lentisco, we provide:
- Market analysis for pharmaceuticals: we conduct a detailed analysis of the pharmaceutical market to identify access opportunities and optimize the entry strategy.
- Pricing and reimbursement strategies: We advise on pricing and negotiations with health authorities to ensure reimbursement and maximize drug accessibility.
- Launch planning: we design launch plans that ensure successful introduction and sustained market penetration, aligned with commercial and regulatory objectives.
- Relations with health authorities: we facilitate contact and negotiations with relevant entities, including the Ministry of Health and the Autonomous Communities, to ensure efficient market access.
