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Regulatory Document Services In USA
45 services found
by:Wood Rodgers based inSacramento, CALIFORNIA (USA)
Wood Rodgers’ environmental professionals are well versed in preparing applications and securing permits at the Federal, State, and local levels. Our experts have prepared legally defensible single compliance as well as complex joint compliance documents for a wide array of our clientele. At the concept level of a project, we draft a Compliance Matrix that identifies all required ...
by:3E - SDS and EHS Compliance Data Management Solutions based inCarlsbad, CALIFORNIA (USA)
3E Company is the industry’s most trusted independent resource for authoring accurate MSDSs / SDSs and regulatory documentation. For situations involving 20 products or less, manufacturers may qualify for a standard service option that provides effective, compliant documents via an easy-to-use automated request ...
by:Certrec Corporation based inFort Worth, TEXAS (USA)
knows where the Information is. Regulatory guide 1.70 and standard review plan cross-referenced to regulatory documents – makes developing license amendment requests more efficient. Always available, real-time information from a single source to support 50.59 reviews, licensing correspondence development, modifications, operability reviews, ...
by:Environmental Waste Services, Inc. based inElburn, ILLINOIS (USA)
EWS handles all the regulatory documentation needed for transportation of waste from your facility to the disposal site. Our permitting division will complete all the necessary paperwork to secure both Illinois and Federal EPA Generator ID numbers, if required. ...
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
Regulatory Submission – Prepare all regulatory approval documents in compliance with Common Technical Documents (CTD) requirements including electronic CTD (eCTD) submission to the FDA. Prior Approval Inspections – Assist with the preparation and participation in the FDA prior approval inspections, and oversee ...
by:Environmental Technology, Inc. (En Tech) based inPhoenix, ARIZONA (USA)
The vicinity reconnaissance provides the client with information on the surrounding properties and how they may affect the environmental conditions of the property of concern. The site reconnaissance compares regulatory compliance documents and historical information obtained from interviews and record searches with observations made in the ...
Manufactured by:Viant Medical based inFoxborough, MASSACHUSETTS (USA)
We can help you engineer your tool or device, from complete process development, testing, and prototyping, to manufacturing documentation and regulatory compliance ...
by:WestWater Research based inBoise, IDAHO (USA)
WestWater typically conducts marketing projects in two phases to allow clients to initially assess marketing prospects and then decide whether or not to pursue active marketing. Phase 1 typically includes a preliminary review of water right documents and the surrounding water markets to identify an estimated value for the water rights and any immediate fatal flaws that would ...
by:MMS Holdings Inc. based inCanton, MICHIGAN (USA)
Forward-thinking medical and regulatory writers that produce cohesive, scientifically-accurate, and regulatory-robust ...
by:O`Reilly, Talbot & Okun Associates, Inc. (OTO) based inSpringfield, MASSACHUSETTS (USA)
We have been conducting ESAs in Massachusetts and Connecticut for decades; this means we know where to go for important information quickly and efficiently. Usually, an ESA includes a review of available historic documentation, regulatory filings and interviews with knowledgeable people, but does not include testing of environmental samples until a Recognized ...
by:Hazox Compliance Solutions, LLC based inAltanta, GEORGIA (US) (USA)
Similar to the Hybrid approach but in this case Hazox licensing is offered as a traditional purchase of software licenses: This solution is adapted to your needs and includes the option of the following ...
Manufactured by:Mettler - Toledo Int. Inc based inGreifensee, SWITZERLAND
There is an ever increasing awareness of the need for assurance that products are safe and of a consistent quality. Consequently, as a manufacturer, you must document that processes are proven and that equipment is qualified to produce results that meet specifications. METTLER TOLEDO has qualification protocols and documentation solutions that satisfy the demands ...
Manufactured by:Precision Medical Products, Inc. based inDenver, PENNSYLVANIA (USA)
Once a device concept has been realized, it enters process design and development. PMP works closely with your team throughout this phase, adhering to design for manufacturing principles to ensure that the device can be produced at anticipated volumes. Are the right processes in place? The right materials? The right workflow? All of these factors must be considered — and verified — to ...
by:BSTI based inCochranville, PENNSYLVANIA (USA)
Our professionals have extensive experience developing industry guidance, international standards, bid specifications and customized procedural documents. We’ve worked independently as well as by leading multi-disciplinary groups for consensus-based standards. Private and public organizations have found us effective for streamlining processes, documenting procedures, and educating employees ...
by:Synthego based inMenlo Park,, CALIFORNIA (USA)
CRISPR cell and gene therapies are revolutionizing medicine, but the journey to clinical trials can be complex. With the expertise of Synthego's regulatory team, CRISPR regulations don’t have to be daunting - you can now transition your therapy from the lab to the clinic seamlessly. ...
by:Triton Environmental, Inc. based inGuilford,, CONNECTICUT (USA)
Tracker is a powerful, internet-based tool specifically designed for use by managers of industrial/commercial operations responsible for environmental and regulatory compliance. In response to client feedback, it was designed from the start to be simple to understand and easy to use. It offers convenient access, ultimate flexibility, effective graphic displays, and many other useful features. The ...
by:Intrinsik Inc. based inMississauga, ONTARIO (CANADA)
Completing a peer review should result in a higher quality product and improve the probability of timely acceptance of documents by regulatory agencies, lawyers, purchasers, or other ...
Manufactured by:AGC Biologics based inBothell, WASHINGTON (USA)
AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have helped us continuously ...
Manufactured by:Aviva Systems Biology Corporation based inSan Diego, CALIFORNIA (USA)
Aviva offers a full line of custom ELISA Assay services including Assay Development, Assay Validation, Clinical Trial Testing, and Clinical (CLIA) Testing. We leverage our expertise in development and validation of antibodies and antigens to reduce development time and improve assay ...
by:ICF based inFairfax, VIRGINIA (USA)
ICF Incorporated provides proven and cost-effective support and tools that help U.S. federal policymakers and regulatory offices meet their responsibilities at all stages of rulemaking. ICF offers a full range of services to assist clients who develop, promulgate, and implement regulations. U.S. federal rulemaking takes place in a complex environment that requires clear and precise drafting, ...