Extended resources strengthen our team of Regulatory Affairs professionals
We are pleased to announce that Sonja Horsted, MSc. Pharm, has joined the Regulatory Affairs team at PharmAdvice on June 1, 2017.
Sonja has more than 25 years of experience from the international pharmaceutical industry within the fields of Regulatory Affairs, Pharmacovigilance, Line Management and Project Management. Sonja’s vast expertise will benefit our clients and strengthen our professional service solutions even further.
PharmAdvice provides professional Regulatory Affairs guidance helping our clients achieve the best within:
- Pre-submission activities, incl. regulatory strategy and scientific advice from authorities.
- Marketing Authorisations, incl. preparation of documentation and submission of applications in eCTD and NeeS format for NP, MRP, DCP and CP, preparation (incl. translations) of summaries of product information, labelling and package leaflets, communication with regulatory authorities.
- Regulatory Life Cycle Management activities, incl. variations, PSUR submissions, renewals and reporting to EudraVigilance XEVMPD.