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S I N T A C T I C A s.r.l.

SERVIZI CHIMICO-FARMACEUTICI

SINTACTICA acts as a contract company to plan and realise new medicinal product, dietary supplements and innovative new pharmaceutical dosage form.

Main activities

Contract research laboratory for pharmaceutical development, pharmacokinetic and bioequivalence studies.

Contract research organisation for pre-clinical and clinical studies.

Manufacturer of dietary supplements according to Italian law (D. Lgs. 111/92).

Regulatory Affairs for pharmaceutics and dietary supplements.

Contact : info@sintactica.it

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INTRODUCTION

SINTACTICA s.r.l. SERVIZI CHIMICO FARMACEUTICI

Stock capital : EURO 72.800,00

Registered office : v.le Ercole Marelli 352 - 20099 Sesto San Giovanni (Milano).

Headquarter, Laboratories : Str. Padana Sup. n°1 - Villa Fiorita - 20060 Cassina Dè Pecchi (Milano) - Tel. / fax (0039) 02 95 34 39 90 - 02 95 34 41 47

Map

By green line underground (MM2) , from Villa Fiorita Station walk 500 metri.

By car : from Tangenziale EST, Cascina Gobba way out, along National Road n. 11, 6 kilometers.

By car : from Motorway A4, Agrate way out, along Departimental Road to Cassina Dé Pecchi, 4 kilometers.

Business relationships

SINTACTICA cooperates with national and international pharmaceutical companies .

SERVICES

Contract research laboratory operating in GLP

Lab scale batches of new dosage form .
Validation of analytical methods for pharmaceutics and biological samples
Pilot batches for preliminary stability studies
Stability studies according to ICH
Part II according to Notice to Applicant or Common Technical Document .
Pharmaceutical Expert Report
Assay of biological samples for pharmacokinetic and bioequivalence studies

Contract Research Organisation

Pre-clinical studies

Planning, managing and monitoring of GLP studies in pharmacology, pharmacokinetics and metabolism .
Pre-clinical Expert Report .

Clinical studies

Planning , managing and monitoring of GCP studies (phase I-IV).
Clinical Expert Report

Regulatory Affairs

Dossiers and applications to Italian or E.U. Authorities

PHARMACEUTICS

SINTACTICA is the Marketing Authorisation Holder of medicinal products manufactured by contract manufacturers and sold by marketing organisation.

Authorised and under development Medicinal products

Doloxtren oral suspension

Disodium clodronate injectable

Nimesulide foam

Lovastatin tablets

Piroxicam foam

Citalopram tablets

Lipoic acid tablets

Clobetasole foam

DIETARY SUPPLEMENTS

Dietary supplements are special foods suitable for people "who are in particular physiological conditions and may take advantage by eating some special nutrients present in foods " [D.Lgs.111/92].

Dietary supplements may include "..all the products that supply a definite amount of vitamins, mineral salts or other nutrients in amount consistent with the food-stuffs". [Cir.8 del 16.04.1996, Ministero della Sanità]

SINTACTICA develops "nutriceutical" supplements to prevent or reduce the risk factors associated to some pathological conditions.

SINTACTICA is a manufacturer of dietary supplements authorised by Minister of Health. The production is made according to GMP , starting from pharmaceutical grade raw material: the content in nutrients and the microbial purity of the product are certified.