Industry Category
Business Keywords
Company Description
Global Biopharmaceutical Regulations Inc has been a trusted partner for small and medium enterprises for over a decade, specializing in documentation preparation and compliance monitoring for clinical and manufacturing operations. Global Biopharmaceutical Regulations Inc is well-equipped to handle filings with US-FDA, EMEA, MHRW, and K-FDA, ensuring adherence to international regulatory standards.
Global Biopharmaceutical Regulations Inc excels in negotiating clinical design and relevant end-points with the FDA and other international agencies, streamlining the regulatory process for its clients. With a focus on regulatory and quality functional areas, Global Biopharmaceutical Regulations Inc stands out with its expertise in auditing international supply chains and in-country language capabilities for India and China, allowing direct interviews with Subject Matter Experts (SME). This approach significantly reduces revisions and editing time when preparing regulatory dossiers.
Global Biopharmaceutical Regulations Inc is committed to providing exceptional service and support to its clients in the biopharmaceutical industry. The information will be completed soon with the support of the company’s management. We invite the manager of Global Biopharmaceutical Regulations Inc to create a customized and exclusive company showcase and product listing on our platform to further enhance their market presence.
Key Personnel / Employees
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Compare Global Biopharmaceutical Regulations with 2 companies in Biotechnology-Research
| Comparison Field |
Global Biopharmaceutical...Main Company |
ONIX Life Sciences L...View Profile |
Snow Leopard Consult...View Profile |
|---|---|---|---|
|
Founded Year
|
— | 2010 | 2020 |
|
Company Size
|
— | 2-10 | 1 employee |
|
City
|
Windsor, Berkshire | Greater Boston, Massachusetts | |
|
Country
|
United Kingdom | ||
|
Skills & Keywords
Comparing with main company
|
25 Total Skills
Biopharmaceutical Regulations
Regulatory Compliance
Clinical Documentation
FDA Filings
EMEA Regulations
Quality Auditing
Supply Chain Management
Training of staff on 21 CFR Part 50
211
820
ISO 14644 (clean room)
submit IND
Prepare
ISO 13485 (medical devices)
600
U.S. Agent (FDA) for overseas firms
BLA
NDA
51
Systems Approach for Leaders
ISO 9000 (general manufacturing)
Inspection of Suppliers
critique
CTD
Operational Excellence
|
22 Total
22 Unique
Unique Skills:
ASMF
CmDh
CTA
CTD MS Word Templates
DMF
eCTD
+16
|
24 Total
24 Unique
Unique Skills:
Biologics
Briefing Booklets
Developmental & Reproductive Toxicology
Gene Therapy
Genetic Toxicity
Health Authority Representation
+18
|
3
Total Companies2010
Oldest Founded1
Countries70
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Alternative Company Names
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