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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.
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.
The Cyrill-Scott Company - Lancaster, OH
Service Company
Printing, security printing, shrink wrapping, stitching, imaging, mail sorting, finishing & FDA compliant printing services.
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.
TUV America - New Brighton, 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.
BarCodeAmerica.com/RDG - Madison, NJ
Distributor, Service Company
Pharmaceutical validation, regulatory compliance, packaging, labeling, warehousing system service
Compliance Gurus, Inc. - Newburyport, MA
Service Company
FDA consulting, auditing, documentation & project management services.
Online Compliance Panel LLC - Fremont, CA
Service Company
FDA compliance consulting services provided.
Selco Engineering - Indianapolis, IN
Manufacturer, Custom Manufacturer, Service Company
Consulting service for control panel systems & assemblies, custom & special machines, systems integration & material handling equip.
Focus Compliance & Validation - Knoxville, TN
Service Company
Compliance & validation services. Compliance services include vendor/supplier qualification & certification programs, good documentation practices & documentation control programs, 21 CFR part 11 (electronic records & signatures) training & remediation, quality systems & validation training, auditing & gap assessments, FDA mock inspections, FDA pre-approval inspections, risk analysis/risk management, ISO 9001 & CE mark, change control, international regulations, quality & statistical tools, design control programs, FDA regulatory submissions & GxP compliance.
TUV America - Clinton Township, MI
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.
TUV America - Knoxville, TN
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.
TUV America - Auburn Hills, MI
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.
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.
Burgess Technical Resources, Inc. - Westfield, NJ
Service Company
Pharma/biotech technical writing, validation & related compliance services.
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