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BioTheraGene
BioTheraGene is a contract research organization (CRO) that provides professional consulting and project management services to pharmaceutical companies, government, and investors in the specialty area of biologics (biotechnology-derived drugs, biotherapeutics). Services include advice on drug development strategy and regulatory requirements, regulatory affairs, due diligence, and design and management of clinical trials.
Biotheragene.com ~
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Horn Pharmaceutical Consulting - ASMF, Active Substance Master File, US-DMF, Drug Master File, Certificate of suitability, CEP, CTA ,Clinical Trial Application, IND, Investigational New Drug Application, CTD, Common Technical Document, European MAA, Marketing Authorization Application, NDA, New Drug Application / BLA, Biologic License Application, SPCs, Summary of Product Characteristics, clinical or nonclinical study protocols and reports, clinical or nonclinical summaries and overviews, quality overall summaries, QOS, CMC-documents, regulatory strategies, Authorities, EMEA, FDA, GMP, GCP, GLP, quality systems, SOPs, training, pharmaceutical, biotechnology, API ,Active Pharmaceutical Ingredient manufacturer, contract manufacturer, contract laboratory, SME, Small and Medium-sized Enterprise, medical device industry, advanced therapy industry, pre-submission, submission, pre-approval, approval, post-approval phase
HORN Pharmaceutical Consulting provides regulatory and business advice to companies from the pharmaceutical, biotechnology and medical device industries.
Horn-pharma.com ~
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