Comprehending the requirements of multiple disciplines is fundamental to our Pharma Services. Our experts in dissolution testing have experience with a wide range of issues, including developing a robust method, analysing samples using different analytical techniques, governing norms and regulations, differently automated instrumentation, characterising APIs, routine testing, stability testing, and more.To fully utilise its potential, one must have a solid understanding of the different sectors that affect results, such as API characteristics, formulation composition, manufacturing process, and biopharmaceutical performance prediction.
![Our CRO specializes in dissolution testing and has a proven track record of finding the most suitable method for a wide range of products, including APIs, tablets, implants, semi-solids, and more.](/fileadmin/user_upload/Images_Ortiv-Q3/04_Highlights/OQ3_highlight_Dissolution_Experts_1090x1090px.jpg)
Dissolution Experts.
Our DNA is in-vitro dissolution testing. Being the only Contract Research Organisation (CRO) with a dissolution testing speciality, our team has a track record of successfully determining the best approach for a wide range of products, including implants, semi-solids, tablets, APIs, and many more.
![Our teams have access to state-of-the-art instrumentation and are experts in mastering different analytical techniques for various types of tests, including API characterization and stability testing.](/fileadmin/user_upload/Images_Ortiv-Q3/04_Highlights/OQ3_highlight_Beyond_Dissolution_1090x1090px.jpg)
Beyond Dissolution.
In-vitro dissolution testing has been Ortiv-Q3's area of expertise since 2019, however the company offers much more than "just" dissolution-related services. Our teams are proficient in many analytical techniques and have access to cutting-edge instrumentation for a wide range of test types, including stability testing and API characterization.
![Ortiv-Q3 Research is committed to providing reliable and quality results in a timely manner by adopting defined procedures, employing qualified and efficient personnel, and implementing a Pharmaceutical Quality system that meets the applicable Good Manufacturing Practices requirements as per US 21 CFR Parts 210, 211 and principles of ICH Q10 guideline.](/fileadmin/user_upload/Images_Ortiv-Q3/04_Highlights/OQ3_highlight_Quality_System_1090x1090px-V2_01.jpg)
Quality System.
In accordance with US 21 CFR Parts 210, 211 and the guidelines of ICH Q10, the management of Ortiv-Q3 Research is dedicated to putting into place a Pharmaceutical Quality system that satisfies the relevant Good Manufacturing Practices criteria. Ortiv-Q3 Research is dedicated to the highest standards of professional conduct and customer service, utilising established protocols, techniques, and skilled and productive staff to deliver dependable, high-caliber outcomes on schedule.
One of three labs – worldwide.
In addition to Ortiv-Q3 in India, SOTAX has two other laboratories in Europe and the USA, all based on the same proven quality management system and offering first-class services in a GMP-certified and FDA-approved environment. Throughout the whole life cycle of your products, our local experts can help you, whether you need assistance with technological development or want to outsource regular testing.
Asia-Pacific
India
Asia-Pacific
India
Ortiv-Q3 Research Pvt. Ltd.
Ratna Business Hub, B-202-207, 2nd Floor
Near Sanathal Circle, Sarkhej - Bavla Highway
Ahmedabad, Pin 382 210, India
P Office +91 76 7670 7801
info@ortiv.in
![To obtain a biowaiver for your complex generic product approval, it is necessary to achieve Q1/Q2 similarity and perform Q3 characterization.](/fileadmin/user_upload/Images_Ortiv-Q3/05_Services/OQ3_RnD_Q3_484x410.jpg)
Europe
France
Europe
France
SPS Pharma Services Sàrl.
3 rue Chateaubriand
45071 Orleans Cedex 2, France
P Office +33 2 34 59 72 61
pharmaservices@sotax.com
![This understanding encompasses both formulation and analytics, with specific competence in small and big compounds, oral and parenteral modes of administration, and immediate and modified release dosage forms.](/fileadmin/user_upload/Images/01_PRODUCTS/11_Pharma_Services/05_Services/Lab_France_484x410.jpg)
Americas
USA
Americas
USA
SOTAX Corporation
2400 Computer Drive
Westborough, MA 01581, USA
P Office +1 508 417 1112
sotaxusa@sotax.com
![Our team helps you find potential reasons and put solutions in place for certain issues that arise during the lifecycle of your goods, from troubleshooting to out-of-specification (OOS) investigations.](/fileadmin/user_upload/Images/01_PRODUCTS/11_Pharma_Services/05_Services/Lab_USA_484x410.jpg)