Summary
consulting, clinical trials, regulatory affairs, REMS, clinical development, Medical Scientific Affairs, Patient Recruitment, Clinical Project Management, Drug Safety, Pharmacovigilance, Medical Writing, Site Start Up, Clinical Operations Management, Quality Assurance, Phase I, II, III, IV, contract research organization, drug Development, CTMS
Classification
- Administrative Management and General Management Consulting Services
- Other Management Consulting Services
- Other Scientific and Technical Consulting Services
- Research and Development in Biotechnology (except Nanobiotechnology)
- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Research and Development in the Social Sciences and Humanities
- All Other Professional, Scientific, and Technical Services
Description
โข Pre-clinical Development โข Phase I-IV Trial Support โข Regulatory Affairs โข Investigational New Drug (IND) Preparation & Filings โข 510(k) โข Trial Design โข Biostatistics โข Medical Writing & Communications โข Site Monitoring โข Compliance Audits โข FDA Readiness Audit โข Risk Management โข Patient-focused Recruitment โข SOP Development & Implementation โข Risk Evaluation and Mitigation Strategy (REMS) โข Pharmacovigilance โข Site Management โข eCTD Dossiers & Publication โข Computer-aided Drug Design (CADD) โข Pharmacokinetics & Pharmacodynamics (PK/PD) โข Drug Metabolism and Pharmacokinetics (DMPK)
Profile
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Incorporated in
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Established since2018
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Main/BranchBranch
Address
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State
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County
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City
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Address8403 COLESVILLE RD STE 1100
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ZIP Code20910-6346
Contact
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Phone
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Fax
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Email
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Website
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Contact PersonSeun Oyewo