ABOUT

ELC Consulting Services provide various complementary quality services for the medical devices, pharmaceutical and biotech industries. If you need to get ready for inspection of FDA, EMA,NAB for CE mark or other official regulatory authorities you should call us to help you get ready. We will make gap analyses of your quality systems and guide you towards corrective actions which will elevate your site to a GMP compliance level that ensure successful pass of the inspection.

We also support you with any other quality related issues like preparing quality manual, writing SOP's, training of personnel, preparing annual product review (APR), RCA, Investigations, Complaints, CAPA, QC (method validation, OOS, OOT, field alerts, SS etc.), cleaning validation, equipment validation and process validation.

ELC owner, Eyal Lerner offers more than 20 years of experience in the pharmaceutical industries after completing several successful roles as quality director, head of accreditation for chemical, biological and GLP of the Israel National Authority for Laboratories Accreditation and audits director at Teva Pharmaceuticals and currently teach at Ben Gorion University course on the regulation and registration of Biomedical product

Eyal own a Ph.D. in Applied Chemistry and B. Pharm from the Hebrew university.

He is a certified pharmacist and quality engineer (ICQE).