Pharmaceutical Testing
Cotecna provides a wide range of pharmaceutical product testing services delivered by our expert teams and using the latest equipment and technical methods.
Pharma testing is a specialized form of laboratory analysis focused on determining the accuracy, strength, and weaknesses of pharmaceutical products. Pharma testing aims to determine the potency, efficacy, and proper dosage and use of medical products, thus ensuring the health and safety of users.
The safe production and consumption of pharma products is strictly regulated. Cotecna can assist you to determine compliance with relevant safety and quality standards. Pharma testing helps mitigate or prevent losses arising from contaminated products, product recalls, and regulatory penalties while promoting consumer confidence and brand positioning.
Pharma Product Scope and Services
Cotecna’s Pharma Testing capabilities include the testing of different product categories such as raw materials, excipients, active pharmaceutical ingredients (APIs), bulk drugs, finished products, herbal products, medical devices, and primary packaging materials.
Our labs are proficient in testing pharma products for contaminants, nitrosamines, pesticides, elemental impurities, pyrrolizidine alkaloids, pharmacopoeia methods, assay & impurities, stress test studies, residual solvents, and stability studies.
The Cotecna Pharma service scope includes:
- Analytical Activities (Chemical/Physical Tests),
- Stability study (According to ICH guidelines ICH Q1),
- Method validation (According to ICH Q2 (R1)),
- Protocol study,
- Analytical Support for Process Validation,
- Analytical Support on Primary Packaging Material choice,
- Cleaning validation,
- Investigation and support on Root Causes Analysis,
- Full Service for ongoing stability studies (zone I, II, IV),
- Annual product review,
- API suppliers auditing,
- Identification of impurities,
- API titration according to specification limit,
- Stress test study,
- Residual test study according to USP,
- ICHQ3D study for metals,
- and nitrosamine investigation activity.
Cotecna Group Pharma Laboratories
The Cotecna Group includes over 140 offices and laboratories across more than 50 countries worldwide. Laboratories under the Cotecna Group utilize best-in-class equipment to deliver detailed analytical results to our clients. Cotecna has three dedicated pharma laboratories in its network, based in Europe and India:
Geo-Chem India
Geo-Chem Laboratories (Rajkot) Pvt. Ltd. is proficient in detailed analysis and offers cutting-edge solutions through its exceptional laboratory and team. The Geo-Chem pharmaceutical product testing laboratory in Mumbai, India (Maharashtra) delivers FDA approved analytical services for clients in the industry. Geo-Chem Accreditations include:
- ISO/IEC 17025: 2017
- Approved by Maharashtra Drug Control
- Department (FDA) for Drugs and Cosmetics
- Approved by Maharashtra Drug
- Control Department (FDA) for AYUSH
Neotron
Neotron offers an "under one roof" service model in its state-of-the-art laboratory in Modena, Italy. Neotron Pharma is a specialized GMP division dedicated to the Analytical Service for the Pharmaceutical sector on API, Drugs, Excipient and Raw Materials. Neotron’s Pharma Accreditations include:
- GMP certificate
- Agenzia Italiana del Farmaco (AIFA) approved
- FDA U.S Food & Drug Administration – facilities inspected
- Ministry of Health – Veterinary drugs
- Ministry of Health – Drugs and psychotropic substances
Shiva Analyticals
Shiva specializes in detailed analytical solutions through its state-of-the-art laboratory and exceptional team. Shiva's advanced pharmaceutical product testing laboratory in Bangalore, India, delivers cGMP compliant and USFDA approved analytical services for clients in the industry. Shiva’s Pharma Accreditations include:
- ISO/IEC 17025: 2017
- Facility audited by USFDA in 2007 and 2016, FEI 3006192929, DUNS N° 91-844-1911
- ISO 9001: 2015 Certified
- ISO 45001: 2018 OHSMS Certified
- Approved by Karnataka Drug Control Department
- Approved by Central Drugs Standard Control Organization
- AYUSH
Visit Shiva Analyticals' website.
Pharma Laboratory Technologies & Capabilities
Cotecna’s Pharma Laboratories are equipped with cutting-edge technology for wet analysis, Micro Contaminant Analysis, HPLC area detectors, GC area detectors and Metal Analysis. This equipment includes, Dissolution Test Apparatus, Disaggregator, Hardness tester, UV-VIS Spectrophotometer, K.F, Densimeter, Viscometer, and Mastersizer.
Also, our laboratories are equipped for the validation of assay/impurities, Nitrosamines, residual solvents and contaminants. DAD, Refractive index, IR, Fluorimeter, Light scattering, MSMS FID, ECD, HS-MS, GC-Head Space and GC-Dual FID Autosampler/Manual. Finally, ICP-OES, ICP-MS, AAS, and Mineralizer for metal analysis.
In addition, Shiva offers UPLC–MS/MS, GLC–MS/MS, LC-MSMS Triple Quad, GLC-MS/MS Triple Quad Purge & Trap, ATR-FTIR, HPLC with UV-VIS, PDA, RI, ELSD, FLD, and VWD Detectors, XRF, BET Surface Area, and Ion Chromatography.