COVID-19 information

Amid present circumstances Eignapharma is technically equipped and ready to maintain same support and service level to all its customers around the world from all its sites.
Hopefully this situation will evolve positively very soon.

Eignapharma is a company operating in the pharmaceutical business engaged in providing services to the industry peers, especially qualified and experienced in Business Development, Pharmacovigilance, Regulatory Affairs, GxP Compliance.

Eignapharma is your partner of choice to:

Identify the best business partners.

Identify the best product/source fit.

Ensure European Pharmacovigilance Compliance.

Meet the European GMP/GDP standards.

Prepare, submit and/or maintain Marketing Authorisations in Europe.

EVDAS: Changes in the electronic Reaction Monitoring Reports (eRMRs)

As of 27-Apr-2020 the current ad-hoc reference period eRMRs will no longer be available for EVDAS. These reports will be replaced by different fixed reference period eRMRs that will cover fixed periods of 15 days, 1 month, 3 months, 6 months and 1 year. The new fixed...

8th Annual Pharmacovigilance Forum – April 3-5 2019, Bratislava

Our Pharmacovigilance Director will be attending the 8th Annual Pharmacovigilance Forum to be held in Bratislava next week within the ‘Future of Healt Summit’ , where relevant experts and speakers from both EU and non-EU Pharma companies will be discussing new...

CPhI South East Asia

Eignapharma participate in the upcoming CPhI South East Asia scheduled to take place in Bangkok, Thailand from March 12thto 14th 2019. We look forward to making new friends and entertaining profitable meetings.

Use of mobile technologies to scan labelling and PL of medicinal products

The EMA has published a document containing the principles and rules of procedure to use mobile technologies to scan the labelling and package leaflet (PL), so patients and healthcare professionals have a different option to obtain statutory or additional information...

Launch of the new EudraVigilance System: Q&A from stakeholders

The EMA has updated their Q&A document on the new EV System; new questions have been added (collected from the Service Desk and from EMA webinars held), and several responses have been updated. The EMA recommends consulting this document before contacting the...

Premis Creatic 2018

Eignapharma is proud to have sponsored the 18th edition of Premis Creatic, an award recognising entrepreneurial projects related to technology and innovation. Eignapharma was invited to be a member of the jury and we must say that all applicants did an excellent work...

World Antibiotic Awareness Week (12-18 November 2018)

Antibiotics have been widely used since their discovery. However, due to overuse and misuse in human and animal health, resistant bacteria have emerged, which has become a public health threat. World Antibiotic Awareness Week intends to transmit this information to...

Workshop on Electronic Product Information (ePI)

On 28-Nov-2018, the European Commission, the Heads of Medicines Agencies and EMA will do a workshop about the electronic formats of the EU product information (SmPC and PL). The aim of this workshop is to create a draft proposal as to how electronic formats can be...

SPOR implementation

SPOR completed one year of live service and remains the highest priority for the EMA. In this period, integrations with electronic Application Form or EudraVigilance registration system took place, and the consolidation with Art.57 and Clinical Trials was also...

Fluoroquinolone and quinolone antibiotics

PRAC recommends restrictions on use of fluoroquinolone and quinolone antibiotics following a review of disabling and potentially long-lasting side effects. Once the CHMP has adopted the final opinion, the new restrictions will become applicable in all EU Member...


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