Company RegPharmaClin
About RegPharmaClin
As data-driven and quality-focused Head of Regulatory Affairs & Clinical Operations collaborates with numerous international Sponsors on multi-country interventional as well as non-interventional trials and provide Regulatory Affairs Services to gain the MAA approval (medical writing of the full dossier (Modules 1 to 5) or assessment of your dossier to gain the approval of the MAA according to your timelines, Post-licensing activities (Variations, Renewals) have sound experience in a wide range of therapeutic areas, new-generation drugs, advanced therapeutic procedures and biologic treatment options.
Medical and scientific expertise in combination with technological and operational know-how have earned established partnerships with numerous Pharmaceutical, CROs, and Biotechnology companies, and experience with veterinary medicinal products, cosmetics, self-care products, generics, medical device, and alimentary supplements clients.
As a Head of Regulatory Affairs & Clinical Operations operates internationally with flexible business models and fully, ICH-GCP -trained operational staff and personnel trained on Regulatory Affairs Guidelines and Procedures.
Pilar Corraliza, CEO & Founder of RegPharmaClin
A Head of Regulatory Affairs & Clinical Operations, Leading Expert on Regulatory Affairs & Drug Development with over 31 years pharmaceutical experience. Provides a full range of services and therapeutic areas including Regulatory Medicinal Products, Biological Medicinal Products, Veterinary Medicinal Products, Generics, OTCs, Medical Devices, Self Care Products, Cosmetics, Biocides, Food Supplements, with proven experience in every developmental stage of drug lifecycle and the latest innovations.
Exceptional competence in corporate quality control and effective stakeholder negotiator for CROs, Clinical Laboratories, Biotech requirements and Private Funding, as well as On-site Audits including facilities. Excellent leadership and communication skills with experience as an Associate Director of a CRO managing a department of five staff, maintaining optimum levels of performance and productivity.
