SERVICES / ANALYTICAL SUPPORT

Qualify for established businesses

Analytical Laboratory

We offer analytical studies in the chemical and microbiological fields, supporting our partners from QC activities to R&D while meeting the high-quality standards of the supervisory bodies.  Our experience allows us to support you at 360°, from raw material control to commercial batch release through a wide range of services, such as:

Stability studies

Binary compatibility

Custom studies

Challenge test

Efficacy tests

We offer effectiveness tests with the highest quality regimens, accompanied by state-of-the-art study protocols to support your products.

Safety tests

We test the safety of your products before they are introduced on the market, from finished products to raw materials, through a proper evaluation process.

Quality control

Each processed product undergoes rigorous control so that you can put a product on the market in full compliance with current regulations.

Microbiological Tests

Careful microbiological controls are carried out according to the official guidelines and methods (ISO, EU/US Pharmacopeia, CTFA, etc.).

Chemical analysis

Ad hoc analyses are carried out upon the customer’s request so that the requirements can be fully met.

CRO

We offer our clients a wide array of services related to clinical/pharmaceutical research.
Services offered by us include product development, clinical trial management (from preclinical to phase IV), clinical and medical monitoring, data management, and statistics.   

We support you in your studies for:

Drugs & Biologics

Medical Devices

Food supplements

Our studies comply with the following guidelines:

ICH-GCP (International Conference on Harmonization)

Good Clinical Practice

Medial Device Regulation(MDR) 2017/745

Medical Devices and Regulation(EU) 2017/746

ISO 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice)

EFSA (European Food Safety Authority)

US - Code of Federal Regulation - Title 21 - Food and Drugs

General Data protection Regulation (EU) 2016/679

Health Insurance Portability and Accountability(HIPAA)

We fully understand and our activities are fully compliant with the regulations of:

FDA – U.S. Food and Drug Administration, USA

EMA – European Medicines Agency, Europe

PMDA – Pharmaceuticals and Medical Devices Agency, Japan

ANVISA – Brazil National Health Surveillance Agency, Brazil

ROSZDRAVNADZOR – Federal Service for Surveillance in Healthcare, Russia

DFDA – Directorate of Food and Drugs Administration, India

CFDA – China Food and Drug Administration, China

BfArM – Federal Institute for Drugs and Medical Devices, Germany

MHRA – The Medicines and Healthcare Products Regulatory Agency, UK