BioInnovatise, Inc.
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Advanced Modalities
Regulatory, Tech Transfer & Support Services
Company Overview
About
BioInnovatise, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2010
Employees:1,545
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval SXV9TK
PMDA · #APR-527LLWZO · 2020-02-01
Drug Approval 97AX1T
FDA · #APR-GO0XOQSP · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ZPQA4IXY
Issued: 2020-09-24
Expires: 2025-07-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-Q37P2BHS
Issued: 2020-11-25
Expires: 2025-01-07
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-S7DHB0U6
Issued: 2020-02-19
Expires: 2025-05-12
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Key facts about BioInnovatise, Inc.
- BioInnovatise, Inc. is headquartered in the United States.
- BioInnovatise, Inc. was founded in 2010.
- BioInnovatise, Inc. has 1,545 employees.
- BioInnovatise, Inc.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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