PHARMAZEUTIKA

To ensure the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA experts support you in your:

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• CMC activities: PDE (Permitted Daily Exposure) Calculation, OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) Calculations, Qualification of impurities, Toxicological evaluation of extractables-leachables, In silico assessment (QSAR)

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• Preclinical development plan: Development plan design, Study monitoring (CROs selection, Validation of protocols & study plans, Study follow-up, Discussion of the results, Review of final study reports), Clinical Trial Applications, Gap analysis

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• Regulatory dossiers: Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents ; Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4) ; Regulatory Toxicology.

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• Environmental risk assessment: Study monitoring, ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6) & Interactions with competent authorities (EMA, FDA) – Defense of the dossier.

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CEHTRA expertise allows you to ensure the:

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      Production safety by minimizing the risk of cross-contaminations (residual active substances from API) and impurities (residual solvents, elemental impurities, impurities with mutagenic potential, extractables & leachables,…)

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      Workers’ safety by calculating occupational exposure limits

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      Patient’s safety by designing adequate development plans and performing robust toxicological evaluations based on in silico, in vitro and in vivo data

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With two main objectives:

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• Safely launch the production of your pharmaceutical product

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• Obtain the Clinical Trial Autorisation and the Marketing Autorisation (MAA)

 

In compliance with:

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      ICH guidelines: ICH Q3A, Q3B, Q3C, ICH M7, VICH GL18, ICH M3(R2), ICH S1A, ICH S1B, ICH S5(R3),…

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      EMA guidelines: Guideline on HBELs 2014, Guideline on control of impurities of pharmacopoeial substances, Guideline on the environmental risk assessment of medicinal products for human use…

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Thanks to a recognized expert team (pharmacists, ERT toxicologists, engineers…)