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Since 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.
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
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aquamarinegroup.info domain lookup results from whois.afilias.net server: Domain Name: AQUAMARINEGROUP.INFO Registry Domain ID: D27797912-LRMS Registrar WHOIS Server: Registrar URL: http://www.register.com Updated Date: 2009-04-18T20:37:34Z Creation Date: 2009-02-17T18:45:27Z Registry Expiry Date: 2019-02-17T18:45:27Z Registrar Registration Expiration Date: Registrar: Register.com, Inc. Registrar IANA ID: 9 Reseller: Domain Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited Registry Admin ID: C60153121-LRMS Admin Organization: The AquaMarine Group Admin Street: 148 Gallows Hill Road Admin City: Redding Admin State/Province: CT Admin Postal Code: 06896 Admin Country: US Admin Fax: +1.2032862322 Admin Fax Ext: Registry Tech ID: C60153124-LRMS Tech Organization: Registercom Tech Street: 575 8th Avenue Tech City: New York Tech State/Province: NY Tech Postal Code: 10018 Tech Country: US Tech Fax: +1.9027492701 Tech Fax Ext: Registry Billing ID: C60153122-LRMS Billing Name: Domain Registrar Billing Organization: Registercom Billing Street: 575 8th Avenue Billing City: New York Billing State/Province: NY Billing Postal Code: 10018 Billing Country: US Billing Fax: +1.9027492701 Billing Fax Ext: Name Server: DNS047.A.REGISTER.COM Name Server: DNS144.B.REGISTER.COM Name Server: DNS045.C.REGISTER.COM Name Server: DNS010.D.REGISTER.COM DNSSEC: unsigned URL of the ICANN Whois Inaccuracy Complaint Form: https://www.icann.org/wicf/
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