Description: 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.
sponsor (1349) capa (96) audits - iso (4) audits - certification (3) audits - due diligence (3) audits - glp (3) audits - gmp (3) clinical - bioanalytical (3) audits - quality system inspection technique (qsit) audits - quality system regulation (qsr)
COMPANY BACKGROUND Since 1996, the services of The AquaMarine Group, Inc. 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, R&D portfolio analysis, contracted management services, and new product/technology evaluation and promotion.
REGULATORY AND QUALITY SERVICES Filing services include review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDAs, ANDAs, INDs (biologicals and new chemical entities), DMFs, 510(k)s, NDSs, ANDSs, MAAs/CTXs and International filings. Other services include due diligence, cGMP audit, Quality Operations (QC/QA), mock pre-approval inspections, R&D portfolio, and Business Analysis, Manufacturing scale-up, Medical devices, Formulation, cGMP Training, SAS, Bioequivalence.
Links: Regulatory Affairs Professional Society American Chemical Society US Food and Drug Administration Linked-in