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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. |
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| BA/BE |
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| Regulatory Inspections |
| USFDA |
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| WHO |
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| Ministry of Health Malaysia |
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| Upto Date Inspection History |
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Mangalore & Manipal |
Laboratory Quality
System compliance |
College of American Pathologists (CAP) & ISO 15189 (NABL) |
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Manipal |
| Lachman Consultant Services, Inc |
GCP, GLP, 21 CFR Part 11 and USFDA requirements |
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Mangalore & Manipal |
| Country Consultancy Ltd |
FDA, EMEA requirements for BA/BE studies |
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Mangalore & Manipal |
| EMA expert GLP Audit |
OECD- Good Laboratory Practice |
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Manipal & Bangalore |
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Central Laboratory |
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| Regulatory Authority |
Inspected Region |
Clinical Trial sites |
CRO Facility |
| Laboratory Quality System compliance |
College of American Pathologists (CAP) & ISO 15189 (NABL) |
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Bangalore |
| Lachman Consultant Services, Inc |
21 CFR Part 11 requirements |
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Bangalore |
| ANVISA |
Facility Inspection |
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Bangalore |
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Clinical Trials |
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