serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Clinical and Bioequivalence Testing

 PTS Pharmaceutical Consulting Global Services offers a range of pharmaceutical consulting services including assay development, validation and sample testing services for Pharmacokinetic studies to support clinical samples in full GCP compliance.

pharmacokinetic clinical testingfacilityMethods are scalable from discovery to the clinical testing, reducing overall development time and costs.

 PTS Consulting Global Services has strategic biostudies/BA/BE CRO partnerships enabling us to provide full statistical services from development to commercial supply of API and formulations.

Through our partner companies like Piramal, we provide a CRO infrastructure to support rapid generic product development by leveraging a network of assets across North America, Europe and Asia Pacific.

 

Partnerships

clinsync logoClinSync is a consolidated dream that has come true of a like minded medical doctors dream focused on research, prominent in their respective therapeutic areas with a vision to be a preferred and globally respected research partner for Pharmaceutical, Biotech, Medical Devices and Healthcare IT companies.

With a mission to achieve their vision by conducting the duties in highly ethical environment and providing ClinSync services with honesty, quality and compliance to our clients, stake holders and employees; They advocate the clinicians, researchers and patients in ethical ways to expedite the development of new medicines and/or technologies that alleviate suffering of the patients.

Click here to go to ClinSync's website for more information.

 

Piramal CROPiramal Clinical Research provides CRO support to Piramal Pharma Solutions, the contract development and manufacturing division of Piramal Healthcare, a leading Indian pharmaceutical company.

We are an integrated service provider, from development to commercial supply of API and formulations along with 103 bed CRO infrastructure to support rapid generic product development. We do this by leveraging a network of assets across North America, Europe and Asia Pacific.

Piramal offers formulations development and cGMP clinical batches along with Clinical BE/early clinical development capabilities as bundled or individual offerings. This includes rapid formulation, BA/BE and human taste/sensory evaluation studies. 

Our CRO works closely with and has successfully passed audits by numerous global regulatory agencies including; WHO, USFDA, UK-MHRA, DCGI, and Chile ANAMED.

Click on an item below to see more information on Piramal Clinical Research

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Contact PTS Global Services