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FDA Compliance & Validation Consulting Services

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The Realtime Group - Plano, TX
Custom Manufacturer, Service Company
ISO 13485:2003 certified FDA compliance & validation consulting services. Capabilities include regulatory compliance strategies, development of test objectives & software maintenance & upgrades. Other services include project management & planning, consulting, inspection, designing, testing, system integration, retrofitting & prototyping.
therealtimegroup.com/value/certification-ca...
Intertech Engineering Associates, Inc. - Westwood, MA Browse our capabilities profile
Service Company
Specializing in software validation, design controls, other quality system regulations. System & software verification & validation services, training & reviews. Production & quality system software validation (820.701) services.
www.inea.com/index.html
Parameter Generation & Control - Black Mountain, NC Browse our catalog of products
Manufacturer, Custom Manufacturer, Service Company
Consulting capabilities include managing & executing projects from stand-alone automated equipment & systems & start-up, commissioning & validation of new facilities, policy & procedures deployment, validation gap assessment & master planning, protocol development & execution, documentation management, change control, URS, FRS, IQ, OQ, PQ & final reports, commissioning & startup programs, equipment, facilities & utilities qualification, process validation, laboratory system validation, stability chamber qualification, revalidation, re-qualification & validation life cycle methodology.
humiditycontrol.com/equipment-services/vali...
North American Sterilization & Packaging Company - Franklin, NJ
Custom Manufacturer, Service Company
ISO 13485:2003 certified FDA compliance & validation consulting services. Capabilities include component sourcing, contract assembly, contract packaging, sterilization, warehousing and distribution, engineering, product commercialization, solvent bonding, soldering, sonic welding, die cutting, impulse, blister and inline form fill sealing, automatic bagging, flow wrapping and labeling. 21 CFR 820 compliant.
naspco.com/Validation-Consulting/
IMET Corporation - Southampton, PA Browse our capabilities profile
Manufacturer, Custom Manufacturer, Service Company
FDA compliance & validation consulting services. Various capabilities include designing, engineering, repair, prototyping, manufacturing, assembly, testing, inspection, analyzing and research and development. Aerospace, automotive, electronic, genetics, nuclear, textile, medical, consumer, military and other industries served. CSA approved. RoHS compliant. CE certified. UL listed. On-time delivery.
Avomeen Analytical Services - Ann Arbor, MI
Service Company
FDA compliance and validation consulting services. FDA approval consulting services for pharmaceuticals, supplements, medical device, containers and food & beverages are available. Capabilities include new product development, safety regulations testing, competitive product analysis, material and contamination identification, imported and domestic product testing, batch to batch variations testing and quality control.
www.avomeen.com/services/regulatory-consult...
Cryopak, a TCP Reliable Company - Edison, NJ
Manufacturer, Custom Manufacturer, Service Company
FDA compliance & validation consulting services for EPS, polystyrene, polyurethane, polyethylene & packaging containers. Capabilities include temperature validation, package designing & UV, shock & vibration testing.
www.tcpreliable.com/industry-leadership/ind...
Intota Expert Network - Minneapolis, MN
Service Company
FDA compliance & validation consulting services. Automation, environmental, product development, energy, software, industrial & manufacturing consulting services are also available.
www2.intota.com/experts.asp?strSearchType=a...
Nutek Corp. - Hayward, CA
Service Company
FDA compliance and validation consultation services for irradiation process verification to meet regulatory requirements. Services available for R&D verification, production validation and turnkey managed validation. Healthcare and medication industries served. Meets AAMI, ASTM and ISO standards.
www.nutekcorp.com/validation-services/
EMS Consulting LLC - York, PA
Service Company
Compliance consulting services. Provides environmental compliance audits; safety and health compliance audits; applying for required permits; developing emergency response plan; environmental reporting requirement assistance; comprehensive or topic-specific OSHA training; and hazardous materials shipping requirements training. Other services include auditing, regulatory compliance, engineering, and training.
Creative Mechanisms, Inc. - Warminster, PA Browse our capabilities profile
Custom Manufacturer, Service Company
FDA compliant & validation consulting services. Various capabilities include engineering, plastic injection molding, rapid prototyping, designing, fabrication, machining, product development and testing. Medical, pharmaceutical, houseware, LED lighting, toy, cosmetics, aftermarket automotive, food packaging, pumps, robotics and merchandising displays industries served. Meets ANSI, ASME and ASTM standards. RoHS compliant. CE certified.
Mulry & Creswell Environmental, Inc. - Glenmoore, PA
Custom Manufacturer, Service Company
Full service environmental consulting & contracting. Environmental testing to remediation to closure. Environmental site remediation & restoration. Underground storage tank (UST) closure & compliance. Environmental site assessments including Phases I - IV. Hydrogeologic studies. Permitting including NPDES, storm water, water quality & groundwater withdrawal. Containment fate & transport modeling. Brownfield's feasibility studies & site development.
IHL Consulting Group, Inc. - Loganville, GA
Service Company
Regulatory & compliance services, operations & system support.
TUV America - Millville, MN
Service Company
Engineering services firm for international safety testing & certification services. Services include electrical & mechanical testing, global conformity assessment services to aid in gaining product compliance to enter individual country markets, FDA reviews & third-party inspection services & EMC & MIL testing for military & aerospace/defense. Accredited managing registrar for ISO 9001, ISO 140001, QS-9000, ISO/TS 16949, TE Supplement, AS9100, ISO 13485, TL 9000, OHSAS 18001, ISO 27000, SQF, ISO 22001 & ESD S20.20 certification services.
SpecialTeam Medical Services, Inc. - Yorba Linda, CA
Manufacturer, Custom Manufacturer, Service Company
Contract FDA complicance & validation consulting services. Turnkey services available.
TUV America - Austin, TX
Service Company
Engineering services firm for international safety testing & certification services. Services include electrical & mechanical testing, global conformity assessment services to aid in gaining product compliance to enter individual country markets, FDA reviews & third-party inspection services & EMC & MIL testing for military & aerospace/defense. Accredited managing registrar for ISO 9001, ISO 140001, QS-9000, ISO/TS 16949, TE Supplement, AS9100, ISO 13485, TL 9000, OHSAS 18001, ISO 27000, SQF, ISO 22001 & ESD S20.20 certification services.
Dicentra - Davie, FL
Service Company
FDA Dietary Supplements Consulting services. Services include product compliance, cGMP compliance, supplier qualification, adverse event reporting and regulatory due diligence.
Terra Labs, LLC - Hialeah, FL
Service Company
FDA compliance consulting. Services include FDA Nutritional and Beverages and Cosmetics Regulatory Compliance.
Robert C. Vincek Design Associates, LLC - Hamburg, NJ
Service Company
Turn key packaging design, development, engineering, project management, & consulting services
Online Compliance Panel LLC - Fremont, CA
Service Company
FDA compliance consulting services provided.
PetroChem - Elmwood, LA
Service Company
Engineering services firm for international safety testing & certification services. Services include electrical & mechanical testing, global conformity assessment services to aid in gaining product compliance to enter individual country markets, FDA reviews & third-party inspection services & EMC & MIL testing for military & aerospace/defense. Accredited managing registrar for ISO 9001, ISO 140001, QS-9000, ISO/TS 16949, TE Supplement, AS9100, ISO 13485, TL 9000, OHSAS 18001, ISO 27000, SQF, ISO 22001 & ESD S20.20 certification services.
PSV ISO Quality Consultants - La Jolla, CA
Service Company
FDA compliance consulting services. Services include consulting in complying with comply with regulatory requirements, such as FDA GMP and 21 CFR 820.
BGF Consulting - Apopka, FL
Service Company
Compliance services. Services include conducting gap analysis, PAI readiness and mock inspections, to developing and implementing comprehensive inspection responses and corrective action plans.
TUV America - Schaumburg, IL
Service Company
Engineering services firm for international safety testing & certification services. Services include electrical & mechanical testing, global conformity assessment services to aid in gaining product compliance to enter individual country markets, FDA reviews & third-party inspection services & EMC & MIL testing for military & aerospace/defense. Accredited managing registrar for ISO 9001, ISO 140001, QS-9000, ISO/TS 16949, TE Supplement, AS9100, ISO 13485, TL 9000, OHSAS 18001, ISO 27000, SQF, ISO 22001 & ESD S20.20 certification services.
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