ELM Pharmaceutical Consultancy

ELM Pharmaceutical Consultancy has a multidisciplinary team of professionals with a wide experience in the pharmaceutical industry. With special emphasis in continuous training, based on annual individual training programmes, allow us to adapt to legislative and operational changes and assuring the compliance of the good pharmacovigilance practices.


ELM Pharmaceutical Consultancy offers an integral pharmacovigilance services. Because our flexible team, we also offer tailor made services adapted to the specific needs of the clients.


Based on our international partners network, we can offer to our clients with a global service in pharmacovigilance in both, EEA-countries and non-EEA countries.

The services offered by ELM are:

Qualified Person Responsible for Pharmacovigilance (EU-QPPV and local)

  • Contact point for Health Authorities (EMA and AEMPS)
  • 24/7 Telephone
  • Backup of the QPPV

Pharmacovigilance System

  • Implementation and maintenance of the pharmacovigilance system
  • Writing of Standard Operating Procedures (SOPs)
  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)


  • Registry in EudraVigilance of the Marketing Authorisation Holder (MAH).
  • Introduction and maintenance of the product information in XEVMPD (Article 57).
  • Electronic reporting of suspect adverse reactions. (EVWEB)
  • Signal monitoring (EVDAS)

Literature search

  • Literature screening in international and local databases.
  • Review of articles for the identification of potential adverse events.
  • Medical Literature Monitoring (MLM)

Preparation and electronic submission of Periodic Safety Update Reports (PSUR) to competent authorities.

  • Preparation of Periodic Security Reports (IPS / PSUR).
  • Submission of PSUR to the competent health authorities.
  • Preparation and submission of documentation required for the initial evaluation of the PSUR by the health authorities.

Risk Management Plan (RMP)

  • Advice in the management of potential and identified risks.
  • Advice in the implementation and follow-up of minimisation risk measures.

Safety Data Exchange Agreements (SDEA).

ELM, as a pharmaceutical consultancy, can manage the preparation of Safety data Exchange agreement. It is a written agreement established between the parties where roles and responsibilities are detailed for each pharmacovigilance activity.

Continuous training in pharmacovigilance.

Continuous training supports improvement of relevant skills, the application of scientific progress and professional development. This is a very important pharmacovigilance service for employees because provides better qualifications, understanding of relevant pharmacovigilance requirements as well as experience for the assigned tasks and responsibilities.

24-hours telephone testing.

We also offer as pharmacovigilance service the telephone test in order to ensure the 24-hour coverage. This test is performed periodically, as defined with client.

Additional services offered by ELM Pharmaceutical Consultancy are:

  • Advice in Regulatory Affairs
  • Medical devices vigilance
  • Cosmetovigilance
  • Advice in registration of food supplements