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Who are we? At B&H, our technical staff can provide expertise and support on all regulatory issues. Our team includes individuals who specialize in the preparation and assessment of the Chemistry, Manufacturing and Controls sections of both US and international submissions, and who are well versed in the format and content of the Common Technical Dossier and electronic submissions. We can provide hands-on support to your company, working off-site or on site at your facility. We also have a separate department of experts who focus on the preparation of IND and NDA annual reports to meet the requirements of 21 CFR. B&H’s technical staff is supported by a document management/ administrative staff with in-depth hands-on expertise in Microsoft Word and Excel, Corel WordPerfect and in various Documentum-based systems. |
55 North Gaston Avenue Somerville, NJ 08876 USA Tel: 908-704-1691 Fax: 908-704-1693 mail@bhconsultingservices.com