Regulatory Affairs Consulting & Services

Mediall consulting & service helps pharma industry and life science companies finding their way to comply with the complex pharma regulatory framework developed to improve patient safety and health. The regulatory expertise includes being supportive of Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Information, CTA, GDP, GMP. Mediall support and provide RA expertise from initial drug development to implementation and post-approval maintenance.

Resources are available for in-house assignments as well as external positions in place at the company (‘bemanning’).

Expertise is available both for regulatory affairs strategies and product development as well as maintenance and support for the affiliate requirements of implementation and compliance. Regulatory expertise is available for pharmaceutical product MAA, variations, PASS requirements, CTA submissions, product information, national catalogue texts, translations, abbreviated texts, labeling and artwork, health authorities databases as well as for OTC, food supplements and the regulatory framework for cosmetics.

Selection of assignments where Mediall has provided regulatory affairs specialist, manager and/or project support since 2016.

Actavis / Teva – Shire Nordic – Gilead Sciences – Sedana Medical – Chiesi Pharma

References available on demand.

For the medtech and consumer supply and distribution part Mediall is working only with the best brands and have carefully chosen products that meet the consumer’s need and are proven to work in a sustainable environment.