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Drug product development Services
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Pre-formulation
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Formulation development
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Analytical method development
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Analytical method validations
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Portfolio development
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Reverse engineering studies
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Complex product characterizations (e.g. peptides, Iron complexes)
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Stability studies
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Technology transfer
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Regulatory services
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Regulatory strategy
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CTD/eCTD dossier preparation support
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Pre-submission strategies (pre-IND, pre-NDA, pre-ANDA, JINAD)
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Post approval change management
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Dossier due diligence
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GMP audits
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Technical, QMS & Facility Due Diligence
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Trouble shooting
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Additional Services partnered with CROs and CMOs
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BA/BE studies
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Pharmacovigilance
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Manufacturing
