Comprehensive solutions for
Human & Veterinary Pharmaceuticals
At CEHTRA, we support pharmaceutical companies in ensuring the safety of their human and veterinary medicines. Our multidisciplinary team of pharmacists, toxicologists, and engineers provides expert guidance across CMC activities, preclinical development, regulatory dossier preparation, and Environmental Risk Assessment. From calculating PDE and OEL/OEB limits to designing preclinical development plans and authoring critical documents, we help you navigate complex regulations and accelerate your path to Clinical Trial Authorisation (CTA) and Marketing Authorisation (MAA).
CMC Support
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PDE (Permitted Daily Exposure) calculation
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OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) calculations
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Qualification of impurities
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Toxicological evaluation of extractables-leachables
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In silico assessment (QSAR)
Preclinical development
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Development plan design
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Study monitoring (CROs selection
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Validation of protocols & study plans
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Study follow-up
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Discussion of the results
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Review of final study reports)
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Clinical Trial Applications
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Gap analysis
Pre-clinical dossiers
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Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents
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Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4)
Environmental Risk Assessment
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Study monitoring
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ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6)
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Interactions with competent authorities (EMA, FDA) – Defense of the dossier
