Our areas of expertise
A partner for all dossier audits, registration strategy,
management of variations, regulatory maintenance,
and with an experience with specific drugs.
Long experience in development strategy, identification of operational service providers, management and coordination of stakeholders, writing of eCTD modules, and client reporting.
The flexibility of an outsourced project management, a single project manager dedicated to your case with an extensive experience in pharmaceutical development and writing, and a tailor-made service.
Quality and Quality Audits
The quality of specialists in audits of API supplier and pharmaceutical excipients, in process quality assessment, and in development of qualification and validation processes.
Advice and Online support
Answers to your questions on all subjects in our areas of expertise, by phone and email. Strategic analyzes and decision-making aids, connection with specialists and the guarantee of a network.
Advice and Coaching
Advice on upgrading your operational sites, assistance in bringing Quality management and risk management systems into compliance, “Inspection” assistance, and coaching services for the Quality functions of management staff