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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
Polaris Compliance Consultants, Inc.

www.polarisconsultants.com
 Quality Compliance
Consultants		 Celine Clive

Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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.

SFP Consulting, LLC

www.sfpconsulting.com

 Regulatory Writing, Consulting, and Training

Susan Sisk, PhD, RAC

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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.