Experts
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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.

To take full advantage of its potential, one must have a solid understanding of the different domains 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.

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.

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.

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.

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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.

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.

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.

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