The Department of Regulatory Affairs and Pharmacovigilance of the LEF provides services to the Pharmaceutical Industry in compliance with the legal requirements applicable to medicines and healthcare products in the National and European context.

Complexity in regulatory aspects requires qualified and specialized resources. Our commitment is to proactively ensure the quality of documentation and demonstrate the quality, effectiveness and safety of our customers' products.

The integration of a Regulatory Affairs department in the organization allows an increase in efficiency in the compliance of the services provided.

Services: Medicines | Human and Veterinary

Regulatory Affairs

• Consulting and regulatory strategy | Regulatory Compliance

• Pre-AIM regulatory activities

o Preparation of new AIM requests (M1-M5)

o Submission and follow-up of AIM requests (National, Mutual Recognition and Decentralized Procedures)

• Post-AIM regulatory activities

o Changes to AIM terms

o AIM renewals

• Prices and reimbursement

• Preparation of Expert Reports (Quality; Non-Clinical; Clinical)

• Information Leaflet Readability Tests | Bridging report

• Technical Translations

 

Pharmacovigilance

• QPPV | Contact Pharmacovigilance Site

• PSMF | Pharmacovigilance System Master File (Preparing and implementing a new PSMF, reviewing | updating an existing pharmacovigilance system, maintaining the pharmacovigilance system)

• Security Reports (PSURs, PGR, ACO)

• Specific training in Pharmacovigilance

• Literature research and review

• Weekly literature search (national | international), weekly MLM (medical literature monitoring) search, evaluation of research results)

• RAMs (Collection, evaluation, notification of ADRs, medDRA coding and case preparation)

• Eudravigilance support

• Registration or updating of products at EXVMPD, electronic notification of cases

Services: Health products (Medical devices; Cosmetics; Food supplements; Biocides)

• Consulting and regulatory strategy

• Preparation of technical documentation

• Preparation of texts associated with products (labelling, product information leaflets)

• Notice of placing on the market

• Post-market activities (legal compliance, amendments)

• Technical translations