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UPCOMING EVENTS

NCRAF's Spring Summit will have a return engagement by former FDA Commissioner

Dr. Robert Califf

 

Wednesday, May 17, 2017

See details.

 

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RAC(US) Workshop Seminar Series
Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm

Location: DCRI, The Lower Level Conference Room (NOTE: This is NOT the Downtown Office)

See Here for Details

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RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

Click to see details

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

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Professional Resources

One does NOT need to be a member of NCRAF to list a resource to this page.
Listings will generally be posted within 48 hours of submission.

 

On this page you will find an alphabetical listing of companies who have the skills and knowledge you may want to access to address your regulatory questions.

 

Company

Type

Contact Information

All Safe Records Management Solutions Inc.

www.allsaferecords.com

Document Shredding And Imaging Services

Susan Meeker

susan@allsaferecords.com

919-201-5073

Secure onsite document shredding available. We bring our mobile shred truck to your home or business. Also offering digital imaging, records retention schedules, training, and records management software.

 

 

Cato Research & Cato Bioventures

www.cato.com

CRO

Regulatory Consultancy

Cato Research

Business Development

1-919-361-2286

 Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients for more than 25 years. Through highly qualified and experienced personnel located in offices across North America, Europe, Israel, India, and South Africa, supported by strategic alliances with selected regional CROs, CATO offers tried-and-trusted international coverage. CATO has the advantage of integrated regulatory, clinical, and scientific expertise. Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 postmarketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutriceuticals, medical foods, devices, and diagnostics. In terms of diseases and indications, in more than 25 years of operation, CATO has been involved in a wide variety of projects. This experience includes leadership of, and involvement in some of the most challenging and innovative products.

Visit Cato Research Online: CATO Services: http://www.cato.com/services.shtml CATO Experience: http://www.cato.com/experience.shtml

 

 

Edgerton Data Consulting

www.edgerton-data.com

Biometrics Project Management

Dawn Edgerton

dawn@edgerton-data.com

(919) 270-3100

Edgerton Data Consulting works with small to mid-size companies that do not have a full-time staff and infrastructure dedicated to data management and statistical services. With 19 years of experience in research computing and CRO operations leadership, we are the small sponsor’s ally in CRO selection and oversight to ensure CRO deliverables are timely, complete, and accurate.

Specialties include: * Finding the best CRO for your clinical trial for data management, CDISC, and statistical services.
* Sponsor representation at key clinical trial project team meetings * Project management * Vendor governance * Verification of CRO deliverables with SAS programming * Vendor coordination * Issues and conflict resolution * RFI/RFP development
* Contract negotiation and pricing * Communications and relationship management * SOP and work instruction preparation/review/revisions * Process improvement and operational streamlining.

 

  

Focus 42, LLC

www.focus42.net

Medical Device Software Consulting

Yuan Xu

focus42consulting@gmail.com

919-360-3488

Focus 42 can aid your project at all stages: market research, creation of a regulatory strategy, software development with integrated design control (21 CFR Part 820), building a Quality System, transitioning your product from R&D to manufacturing, and product launch. We can engage with your project for final software validation, preparation of the FDA submission package, obtaining clearance for your product, and correctly managing design changes that occur at any stage. We also provide gap analysis, project remediation, and staff training.

 

 

Oneresouce Regulatory

www.onesourceregulatory.com

Regulatory Consulting

Tracy Rockney

tracy@onesourceregulatory.com

610-283-3067

Regulatory Advertising & Promotion Review; Medical Review (advertising and promotion, independent scientific exchange materials, grant requests, and independent research study proposals); Legal Review (advertising and promotion, basic business legal services); Labeling development (TPP, CCDS, and local label development, including US PI, EU SPC); Commercial Compliance (monitoring and policy development).

 

 
Polaris Compliance Consultants, Inc.

www.polarisconsultants.com
Quality Compliance
Consultants
Celine Clive

CMClive@polarisconsultants.com

919-463-0003 X111

Polaris Compliance Consultants, Inc. has 15 years experience in supporting quality research. We provide auditing, training, and writing pertaining to GCP, GLP, CGMP, and Part 11 regulations for the pharmaceutical, biotech, medical device, and dietary supplement industries. Auditing: Through our network of employees and independent contractors located in Russia, Uganda and across the United States, our experienced auditors (some of whom are ex-FDA inspectors) have conducted GCP, GLP, GMP, and CSV/Part 11 audits of investigative sites, sponsors, CROs, IRBs, non-clinical laboratories, and manufacturing facilities at domestic & international sites. Writing: Our experienced writers have produced documents in a wide variety of therapeutic areas including, but not limited to: SOPs, protocols, Investigator Brochures, SAE narratives, ICH E-3 compliant Final Study Reports, & INDs/NDAs. Training: Polaris has delivered training on a wide variety of topics to personnel with all levels of experience.

 

Regulatory Affairs, North America, Inc.

www.ranainc.com

Regulatory Consultancy

Nancy Chew

nchew@ranainc.com

919-479-9956

Regulatory strategy - full registration plans to responding to information requests/483s Pre-IND/IND - identifying and organizing required data, product-particular issues, and submissions.  Regulatory Research - online and via personal network.  505(b)2 NDAs - appropriateness of route, definition of variance from ANDA, negotiations with FDA.  Regulatory Communications Expertise - review and comment on documents being prepared for submission to FDA.  Drug and Biologics - decades of experience both with U.S. and European companies.  Devices - combination products including inhaled drugs, "patch" dosage forms.  Orphan Products - designations, development plans, FDA interactions.

 

 

SFP Consulting, LLC

www.sfpconsulting.com

Regulatory Writing, Consulting, and Training

Susan Sisk, PhD, RAC

susan.sisk@sfpconsulting.com

919-338-2785

SFP Consulting, LLC (Susan Sisk, PhD, RAC) specializes in regulatory and medical writing for health product development programs and offers consulting services for submissions strategy.  Writing and review services: preparing clinical trial protocols and CSRs (Phases 1-4), other IND components, NDA components (eg, ISE and ISS, all components of CTD 2.7 clinical summary, clinical overviews, and elements of Module 1 including package insert), briefing packages, journal articles, slides and scripts for Advisory Committee meetings, and scientific posters.  Consulting services: optimizing processes and timelines for NDA submissions, eliciting and disseminating key messages, and participating in Advisory Committee mock meetings.  Training services: providing workshops on CTD clinical content, preparing regulatory submission documents, and process optimization.

Dr. Sisk has experience in the following therapeutic areas: neurology, oncology/carcinogenesis, gastrointestinal, dermatology, pulmonary disease, endocrinology, cardiovascular, wound healing, infectious disease, genitourinary function, and orthopedic surgery.