Regulatory Affairs

MEDICINES

ELM can support you from strategic regulatory affairs activities with highly added value to operational and procedural regulatory activities aimed to get authorizations swiftly and efficiently, assuring both quality and safety of medicinal products during its complete life cycle.

Our experience but also versatility in regulatory affairs enables us to offer to our clients and adapted service to their situation, making bureaucracy an easy path to marketing the product, saving time and money.

We assist our clients with regulatory affairs services at EU level in centralized, decentralized and mutual recognition procedures, coordinating the regulatory activities with all concerned member states and medicines agencies due to our knowledge of the specific requirements and procedures in the different countries of the European union.

Moreover, we support foreign companies at national level, in Spain, as their local contact to support with all regulatory procedures and regulatory affairs activities through the national platforms and applications as RAEFAR, LABOFAR, IMH (human importation medicines), MSE (special situation medicines), GESFARMA, and also providing valuable advice and acting as the contact with the Spanish medicines agency (AEMPS) and the health ministry.

CLINICAL TRIALS

Our experienced and flexible regulatory affairs team provides a reliable and adapted service to our clients to act as local contact in Spain, managing all regulatory activities to obtain the authorization of the clinical trials.

We coordinate for our clients the regulatory affairs operations between the sponsor and the hospital centers, investigators, ethics committees and Spanish medicines agency (AEMPS). We provide efficient service compliant with deadlines.

It is crucial to have the experience and knowledge with the bottlenecks to avoid delays on the authorization which can have an impact on the clinical trial development.

We support our clients at EU level, with the EudraCT database management, to obtain the EudraCT number for the clinical trial, and creating and posting the clinical trial application.

At national level, we provide regulatory affairs advice and coordination to all parties, giving support from the initial application till the end of the clinical trial.
In the first application we help our clients preparing and reviewing the documentation as the protocol, insurance certificates, investigators brochure, labelling, patient information and gathering all other relevant documentation as declarations and certificates.

During the lifecycle of the clinical trial we assist with the preparation and submission of substantial amendments, centers updates, clinical trial reports (Hoc reports, (development safety update report (DSUR), final results report) and trial closure notification.

FOOD SUPLEMENTS

Our team provides a reliable service for the regulatory affairs activities concerning food supplements, both at EU level and at national level, in Spain. Given that in Spain there is not specific regulation for food supplements (except for minerals and vitamins), we support with documentation preparation and notification to the European authorities as Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (in belgium), DGAV – direção geral de alimentação e veterinária (in portugal), the BVL (in germany), …

After the approval at EU level we support our clients with the Commercialization notification in Spain to enable the commercialization of the product.

It is crucial for food supplements the advertising, for which there are specific regulation in Spain. We assist our clients not only with regulatory affairs activitis but also with the review of the promotional material, giving specific advice aiming to have a compliant material and valuable for the patient and avoiding penalties by the authorities.

COSMETICS

ELM pharmaceutical gives full support with regulatory affairs activities for Cosmetics. Since the safety evaluation of the product to the review of the user information. At EU level we make the notification through the Cosmetics products notification portal (CPNP), preparation of the safety evaluation report and we give galenic advice.

At national level, we assist our clients with the responsible person notification and importation and manufacturing declarations.

In addition, we support with regulatory affairs advice, review and preparation of the label information for the product to be compliant with the regulation.

MEDICAL DEVICE

ELM pharmaceutical provides support to our clients for the regulatory affairs activities with medical device, as well.

We support clients with the documentation preparation for the dossier registration submission, modifications applications, functioning license obtention, renewal of the license, and CE certification file obtention and approval by the Spanish agency (AEMPS).

Moreover, we support with regulatory affairs advice during review of the promotional material, the labels, and the medical device instructions aiming to provide the patient with clear, objective and truthful information compliant with the regulation.