Maxer achieves the qualification of SME according to EMA
Maxer is now included in the EMA Register of micro, small or medium-sized enterprises (SMEs), gaining the possibility to benefit from the provisions for administrative and financial assistance laid down in Regulation (EC) No 2049/2005.
Following this qualification, Maxer can now provide its customers with more competitive support for their regulatory and investigational needs, thanks to the EMA direct support in clinical development-related activities including among others:
- direct assistance on the regulatory aspects of the pharmaceutical legislation;
- assistance with pre- and post-authorization regulatory procedures;
- assistance with translations of product information into all official European Union (EU) languages;
- guidance on clinical data publication;
- liaison with academic investigators in paediatric-medicine research through the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA).