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Providing clear and simple solutions to all CMC problems

Welcome to Aquasol-Solutions, Inc. We are a professional Drug Regulatory Affairs (DRA) consulting firm. We are a knowledgeable team with over 10 years of experience managing DRA departments in the pharmaceutical industry, expertise in regulatory document package preparation and submission supported with a strong academic publication record in pharmaceutical sciences, and CMC review experience at the US FDA. Aquasol Solutions leverages this combined expertise to provide quality regulatory services to clients in accordance with its mission.
OUR MISSION Aquasol Solutions, Inc. is dedicated to provision of clear and simple regulatory solutions to drug manufacturing and registration problems, including drug testing and storage and preparation and submission of clear and logical new and supplemental IND, NDA, ANDA, DMF, etc, drug application packages. We listen, analyze and provide regulatory solutions to whatever chemistry, manufacturing & controls problem you may have.	SERVICES Provide strategic recommendations on drug manufacturing, testing and storage during drug development or life cycle phases. Preparation and submission of new IND, NDA, ANDA, DMF, CTX, etc, drug application packages, including supplements and amendments. Regulatory assessment and justified recommendation of filing category on CMC changes, including changes/updates to product test methods, specifications and stability study protocols/reports. We will even provide assigned risk levels to our regulatory CMC assessments, if required. Experience preparing and conducting numerous face-to-face meetings with US FDA on CMC submission and compliance issues. QA/cGMP documentation and batch record reviews. Training on package preparation and general regulatory affairs. Call us today (314) 484-3074 Or click here to E-mail us.
RESOURCES Useful regulatory links for our visitors. US FDA Home: http://www.fda.gov/default.htm US FDA Guidance Page: http://www.fda.gov/cder/guidance/ US FDA Orange Book: http://www.fda.gov/cder/ob/docs/preface/ectablec.htm US Approved Inactive Ingredient: http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm 21 CFR Online: http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321 ICH – International COference on Harmonization: http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254 EU - EMEA Medicines Agency: http://www.emea.eu.int/home.htm UK - MHRA Medicines Agency: http://www.mhra.gov.uk/ Canadian - Therapeutic Products Directorate: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html Australia - Therapeutic Goods Administration - http://www.tga.gov.au/