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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

[email protected]

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

 

 

 

DTS Language Services

www.dtstranslates.com

 

Certified Translation Services

Duncan Shaw

[email protected]

919-582-0330

 Certified Translations of Regulatory and Life Sciences documents in over 100 languages. 24/7 Telephone interpreting services.

 

   

Edgerton Data Consulting

www.edgerton-data.com

Biometrics Project Management

Dawn Edgerton

[email protected]

(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.

 

  

 

FDA Consulting, LLC

www.fda-consulting.com

 

Regulatory Consultancy

Michael Wienholt

[email protected]

(760) 532-6304

  Regulatory Affairs and Quality Management Systems Consulting Services for the Medical Devices & In Vitro Diagnostics Industries. We can assist you in understanding domestic and international regulations and delivering your products to market in a timely fashion.

 

Focus 42, LLC

www.focus42.net

Medical Device Software Consulting

Yuan Xu

[email protected]

919-360-3488

Focus 42 provides consulting expertise for Medical Device SOFTWARE DEVELOPMENT, In Vitro Diagnostics (IVD), Mobile Medical Applications (MMA) and Software as a Medical Device (SaMD) for FDA/EU/cFDA compliance. Services include:

    • Regulatory Strategy and Submission in US, Canada, EU, and China. (e.g. 510(k), De Nova, PMA, CE marking)
    • FDA Warning Letter/483s Remediation
    • Streamline the Quality Management System using the least burden approach. (e.g LEAN process for CAPA, eMDR, Compliance Handing, Design Change Control and Validation)
    • Provide Solutions for UDI requirements, Cybersecurity, Risk Management and Software Change Control (e.g., Continuous Delivery in Agile Development)
    • Device Registration and Listing

 

KC Biopharma

www.kcbiopharma.com

Regulatory Consultancy

Kamali Chance, PhD, MPH, RAC

[email protected]

919-667-8507

 

Dr. Kamali Chance is a highly experienced regulatory professional ready to assist your organization in: *Optimizing regulatory consultations with FDA/EMA with superior Briefing Packages; *Streamlining clinical development plans for first to market strategies -Developing optimal global regulatory strategies and regulatory roadmaps; *Providing critical reviews of regulatory dossiers to ensure one cycle approvals. Dr. Chance continues to lead the regulatory strategy and clinical development plans for the development of number of innovative drug/device, biologic/device, and cell therapy products.

Dr. Chance’s tenure, in addition to supporting 505(b)(2) regulatory strategy and dossier preparation, includes extensive experience in helping companies develop cutting edge regulatory strategy, briefing packages and interactions with both FDA and EMA for biosimilars of Enbrel, Remicade, Herceptin, Rituxin, Humira, Avastin, Epogen, Lucentis, Aranesp, Neupogen, Neulasta, Fabrazyme and Cerezyme among others.

 

 

Oneresouce Regulatory

www.onesourceregulatory.com

Regulatory Consulting

Tracy Rockney

[email protected]

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

[email protected]

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.

 

 

Quality & Regulatory Consulting, Llc

www.qandrconsulting.com

 

 

Regulatory Affairs; Quality Systems

James Clinton

[email protected]

919-247-0479

  Compliance and Remediation: FDA 483 / Warning Letter response, Strategic planning to sustainably correct inspection deficiencies Regulatory Affairs: Medical Device 510(k) and PMA preparation, Drug CMC preparation, US Agent services for foreign device manufacturers doing business in US Process Validation: Validation Master Planning, Facilities, Utilities, Equipment qualification, process validation, sterilization / aseptic process validation Quality Systems: Quality Manual and Quality SOP's - compliant with 21 CFR 210, 211, 21 CFR 820 and international standards (ISO 13485) custom prepared to meet your needs.

 

 

Regulatory Affairs, North America, Inc.

www.ranainc.com

Regulatory Consultancy

Nancy Chew

[email protected]

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.

 

 

S2 Lingua

www.s2lingua.com

Certified Translation Services For Regulatory And Medical Documentation

Matt Schexnayder

[email protected]

919-709-3119

  S2 Lingua translates medical and clinical trial documentation for CROs, pharma, biotech, and medical device companies. Our team consists of certified medical translators and in-country cultural consultants. We offer translations in a full range of therapeutic areas and ensure that they are accurate, culturally adapted, and comply with regulatory requirements. S2 Lingua’s ISO 17100 certified quality control system involves multiple rounds of review by medical translation specialists. We’re specialists in COA translation and ensure that foreign PRO instruments and questionnaires are conceptually equivalent. In addition to maintaining client-specific translation memories and terminology databases, we can localize clinical apps such as eCOA.

 

 

SFP Consulting, LLC

www.sfpconsulting.com

Regulatory Writing, Consulting, and Training

Susan Sisk, PhD, RAC

[email protected]

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.