Welcome to The AquaMarine Group, Inc.
Description
pulled from site's meta descriptionSince 1996, The AquaMarine Group, Inc.’s services have been sought and retained by pharmaceutical firms, to furnish expertise in the areas of regulatory review, application writing, cGMP compliance/mock pre-approval audit services, R&D portfolio analysis, contracted management services, and new product/technology evaluation and promotion. Services furnished to clients include not only review and commentary, but have also included project management for a number of significant filings.
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Categories:
- AboutUs AutoGen
- Audits - Certification
- Audits - Due Diligence
- Audits - GLP
- Audits - GMP
- Audits - ISO
- Audits - Quality System Inspection Technique (QSIT)
- Audits - Quality System Regulation (QSR)
- Sponsor
- CAPA
- Clinical - Bioanalytical
- Clinical - Labeling
- Clinical - Research
- Clinical - Study design
- Cosmetics
- Design Controls
- Electronic Records & Electronic Signatures/ 21 CFR Part 11
- Environmental Monitoring
- Failure Investigations
- FDA
- FDA - 483 and Warning Letter responses
- Consent Decree Remediation
- Hazard Analysis
- ISO
- ISO - 13485
- ISO - 9001
- ISO - 9002
- MCA
- Metrology/Calibration
- Out-of-Specification (OOS) Investigations
- Preventive Maintenance
- Quality Assurance
- Quality Control
- Quality Management
- Quality Systems Development/Implementation
- Regulatory Affairs
- Regulatory Strategy Consulting
- Quality Programs
- SOP Development
- Stability Programs
- Submissions - 510(k)
- Submissions - BLA
- Submissions - CMC
- Submissions - Combination Products
- Submissions - ELA/PLA
- Submissions - IDE
- Submissions - IND
- Submissions - NDA/ANDA
- Submissions - PMA
- Telemetry
- Training
- Chemistry and Manufacturing Controls
- CTD
- eCTD
- NDA
- ANDA
- IND (biologicals and new chemical entities)
- 505(b)(2)
- DMF
- 510(k)
- ANDS
- MAA
- CTX
- International filings. cGMP (QC/QA)
- due-diligence
- mock pre-approval inspections
- R&D portfolio Analysis
- Analytical Chemistry
- Analytical Method Development
- API/Bulk Chemical Processing
- Aseptic Processing
- Biologic - Biologic - Biotech
- Biologic - Vaccines
- Biotech
- Chemistry
- Chemistry - Drug
- Clean Rooms - Design and qualification
- Clean-In-Place (CIP)
- Commissioning
- Document Controls
- Manufacturing
- Engineering - Process
- Engineering - Project
- Infectious Diseases
- Information Systems
- Internal Medicine
- Laboratory Animal Science
- Laboratory Controls
- Laboratory Information Management Systems (LIMS)
- Lasers
- Lyophilization
- Medical Device - Durable
- Medical Device - Sterile
- Medical Writing
- Microbiology
- Nutraceutical
- Packaging and labeling
- Pharmaceutical - Creams & Ointments
- Pharmaceutical - Non-Sterile Liquids
- Pharmaceutical - Solid Oral Dosage Form
- Pharmaceuticals - API/ Bulk Chemicals
- Pharmaceuticals - Parenteral
- PLC Programming
- Process Optimization
- Program Management
- Project Management
- Quality Engineering
- Risk Analysis
- Solid Dosage Forms
- Sterilization
- Sterilization - Aseptic
- Sterilization - Dry Heat
- Sterilization - ETO
- Sterilization - Gamma
- Sterilization - Steam
- Technical Writing
- Validation - Analytical Method
- Validation - Cleaning
- Validation - Computer Control System
- Validation - Equipment
- Validation - Facility
- Validation - Process
- Validation - Retrospective