Welcome to Altamedics.
Altamedics cooperates closely with its partners in order to develop effective strategies for registering every individual product. We understand that speed is one of the critical factors to success, and this is the reason we have made a great effort to assemble an expert staff that can manage your product registration.
Our expert staff dealing with regulatory affairs will:
- Provide end-to-end management of the regulatory process.
- Manage document control and procedures.
- Supervise the coordination of regulatory advisors at the local level.
- Closely manage relations between regulatory authorities and marketing authorization holders.
- Prepare expert translations of product information and labeling, in compliance with local requirements.
- Maintain up-to-date information of EMEA, local standards, and the procedures for regulatory submissions.
- Ensure compliance with the Pharmacovigilance System.
- Ensure pharmacovigilance and Medical Education.