Bcg-usa.com provides FDA regulatory compliance consulting
Title
Biologics Consulting, Group Inc. - Regulatory Affairs Consulting for the Biologics Industry
Description
Excerpted from the website description:
- Biologics Consulting Group, Inc. provides regulatory and product development advice to manufacturers of products regulated by CBER and CDER of the FDA. Our staff consists of experts in regulatory affairs product manufacturing and testing pharm/tox statistics and clinical trial design/evaluation.
Languages
English
Contact
Additional Information
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- WHOIS for Bcg-usa.com
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Categories:
- Amendment
- And
- Annual Report
- Application
- Audits
- BLA
- Biologics
- Biologics Consulting
- Biostatistics
- CBER
- CBER Expectations
- CDER
- CGMP
- CMC
- California
- Center
- Chemistry
- Clinical
- Compliance
- Consulting Services
- Drug
- Evaluation
- FDA
- FDA Policies
- Facility Validation
- Food And Drug Administration
- For
- GMP
- Guidance
- Guidelines
- IND
- Inspections
- Investigational New Drug
- Investigator's Brochure
- Manufacturing
- Master File
- North Carolina
- Orphan Drug
- PAI
- Pharmacology
- Phase I
- Phase II
- Phase III
- Pre-IND
- Pre-approval Inspection
- Preclinical
- Process Validation
- Product Management
- Program Management
- Protocol Design
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Policy
- Research
- Sponsor
- Submission
- Supplement
- Toxicology
- Validation
- Virginia