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Global Regulatory Affairs - Centaurus Consulting Group

Centaurus Consulting Group supports the Biotech/Pharma industry by providing IT solutions, regulatory and project management services for CMC activities.

http://www.centaurus-consulting.com/

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Global Regulatory Affairs - Centaurus Consulting Group | centaurus-consulting.com Reviews

https://centaurus-consulting.com

Centaurus Consulting Group supports the Biotech/Pharma industry by providing IT solutions, regulatory and project management services for CMC activities.

INTERNAL PAGES

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1

Our Services - Centaurus Consulting Group

http://www.centaurus-consulting.com/Services.htm

Global Regulatory Affairs Services. Centaurus Consulting Group supports the Pharmaceutical/Biotech industry by providing services in CMC, Regulatory, Quality, Project and Process Management to development and approved products. Manage and execute Tech Transfer (manufacturing and/or testing). Manage and execute Validation (strategy, protocol, report). Review of Historical Source Documents to support an NDA/BLA. Support with Technical documents. Support with implementation of QbD.

2

CMC - Centaurus Consulting Group

http://www.centaurus-consulting.com/services/cmc.htm

Global Regulatory Affairs Services. Manage and execute tech transfers (manufacturing and/or testing). Manage and execute manufacturing process validation (strategy, protocol, report). Review of historical source documents to support regulatory submissions (NDA, BLA, MAA). Review of existing specifications, manufacturing processes and analytical procedures. Preparation of regulatory documents to support clinical trial applications, marketing applications, annual reports and variations.

3

Due Diligence - Centaurus Consulting Group

http://www.centaurus-consulting.com/services/due-diligence.htm

Global Regulatory Affairs Services. Whether you are considering acquiring a product or company, or whether your business is set for sale, due diligence is in order. The process includes a thorough review of the technical, quality and regulatory documents, along with a gap analysis and implementation of a remediation plan if necessary. Contact us to further discuss your needs and initiate a Due Diligence. Web Development Hudson Horizons.

4

Quality - Centaurus Consulting Group

http://www.centaurus-consulting.com/services/quality.htm

Global Regulatory Affairs Services. Preparation of Pre-Approval Inspections. Audit and/or qualification of CMOs/CROs. Review of executed batch records. Review of specifications (. Web Development Hudson Horizons.

5

Regulatory - Centaurus Consulting Group

http://www.centaurus-consulting.com/services/regulatory.htm

Global Regulatory Affairs Services. Draft and review of CTD sections for global submissions. Module 2 (2.3.QOS). Module 3 (3.2.S, 3.2.P, 3.2.A and 3.2.R). Review of all “attached” documents associated or submitted with Module 3. Paper and/or electronic filing. Marketing Application (NDAs, BLAs, MAAs). Major variations (Prior-Approval Submissions, Type II, MAV…). Minor variations (CBE30, Type IA, Type IB, MIV…). Notifications (CBE0, Type IAIN…). Meeting with Health Agencies (Preparation, meeting minutes).

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