ECRON ACUNOVA
 
 
 
 

Ecron Acunova Quality Reflection



Managerial requirements (Quality Management Systems):
ISO 9001:2008: for all business verticals and support functions


Global offices operating under an unified QMS ensures that the quality of delivery remains consistent, independent of the location of the delivery. The harmonized set of procedures for all key processes has been implemented globally and is meant to comply with all applicable regulations and guidelines.

BVMA certificate: International and national regulatory requirements for continued membership of the BVMA e.V., Germany.

We are a co-founder (amongst first 8 CRO’s) of BVMA (Bundesverband Medizinischer Auftragsinstitut, Federal Association of Contract Research Organizations) and now there are more than 39 CROs involved.

Information Security Management System:
ISO 27001:2013 for all business verticals


Ensuring customer information remains confidential is of paramount importance and hence the ISMS implemented ensures that the information remains secure in both electronic and physical formats and is only transmitted on need-to-know basis.
     
Audit certificate: BVMA  
     
Audit certificate: ISO 9001  
     
Audit certificate: ISO 27001  
     
Marketing Authorizations: BA/BE  
     
Marketing Authorizations: Clinical Trials  
     
Ecron Acunova Company Wide Inspection History  
 
BA/BE
 
Regulatory Inspections
USFDA
 
WHO
 
Ministry of Health Malaysia
 
Upto Date Inspection History






Mangalore & Manipal
Laboratory Quality
System compliance
College of American Pathologists (CAP) & ISO 15189 (NABL) Manipal
Lachman Consultant Services, Inc GCP, GLP, 21 CFR Part 11 and USFDA requirements Mangalore & Manipal
Country Consultancy Ltd FDA, EMEA requirements for BA/BE studies Mangalore & Manipal
EMA expert GLP Audit OECD- Good Laboratory Practice Manipal & Bangalore
 

Central Laboratory

 
Regulatory Authority Inspected Region Clinical Trial sites CRO Facility
Laboratory Quality System compliance College of American Pathologists (CAP) & ISO 15189 (NABL) Bangalore
Lachman Consultant Services, Inc 21 CFR Part 11 requirements Bangalore
ANVISA Facility Inspection Bangalore
 

Clinical Trials

 
Regulatory Authority Inspected Region Clinical Trial sites CRO Facility


USFDA
India (4)  Frankfurt office (1)
Germany (3)
Czech Republic (2)


EMA
Japan (2)

 

Australia (1)  


DMA (Danish Medicines Agency)
Denmark (3)  Denmark Office (2)


French  (ANSM)



Czech authorities
Czech Republic (1)

 



German Local Authority (association with BfArm)

Germany (7)

Frankfurt office (3)
Constance Office (3)



LMV (Läkemedelsverket)

Sweden (1)

 



Russian Federation's Ministry of Health

Russia (1)

 



DCGI

India (16)

India Office (2)

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