+7 499 550 66 53

Registration

BridgePharm company to provide services of high quality on carrying out all phases of clinical trials (I-IV) of medicines on favorable terms.

Successful cooperation with medical institutions and investigators with significant experience in different nosology groups allows to quickly select the most suitable clinical sites for the most complex research activities.

 

Filing and compilation of registration dossier

·        Regulatory support, communicating state bodies

·        Obtaining regulatory permissions

·        Assessment of the validity of the administrative documents (licenses, powers of attorney, certificates)

·        Development of normative documentation, validation of analytical methods

·        Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) development

 

 

Development of normative documentation

·        Original medicines

·        Biosimilar products

·        Generic products

·        APIs

 

 

Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) development

·        Original medicines

·        Biosimilar products

·        Generic products

 

 

Design of the packaging

·        Primary and secondary packaging layouts in accordance with national regulations

 

 APIs registration 

·        Normative documentation

·        Development and submission of additional materials upon MoH requests

·        Submission of products samples for examination by the national expert body

·        Execution of preliminary product examination to ensure compliance with analytical methods

 

 

 

 Variations management and submission 

·        Normative documentation

·        PIL, SmPC, Packaging

·        Development and submission of additional materials upon MoH requests

·        Submission of products samples for examination by the national expert body

·        Rx-OTC transfer

 

Execution of preliminary product examination

·        Ensuring compliance with analytical methods outlined in normative documentation

 

 

Validation of analytical methods

·        Independent examination of documents and samples, provided analytical methods

Home Page Preclinical studies Data management Clinical trials

Full name:
LLC «BRIDGE PHARM»

Adress:
119571, Moscow, Str. 26 Bakinskikh Kommisarov, 5, office 3

Details:
OGRN 1137746964630
INN 7708799217 KPP 770801001

+7 499 550 6653
SHOW ON MAP