Professional Resources

Company

Type

Contact Information

All Safe Records Management Solutions Inc.

www.allsaferecords.com

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.

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

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-consultingllc.com

Regulatory Consultancy

Michael Wienholt

[email protected]

(760) 532-6304

  FDA Consulting, LLC specializes in global regulatory strategies, submissions and quality management systems for medical devices and in vitro diagnostics. Our goal is the client’s success, while maintaining a focus on regulatory and quality compliance.

Focus 42, LLC

www.focus42.net

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

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.

Lindsey Regulatory Affairs Consulting, LLC

www.lracs.com

Sequita Lindsey

[email protected]

919-316-8037

Lindsey Regulatory Affairs Consulting, LLC (DBA, LRA Consulting) strives to meet the needs of the client in every way. We are committed to the success of your business and strive to help you develop and implement regulatory and quality solutions catered to your needs. Our team of consultants bring over 20 years of combined experience in Regulatory Affairs, Quality Assurance, and Clinical Affairs with a proven track record of executing global strategy techniques in a timely and cost efficient manner.

Oneresouce Regulatory

www.onesourceregulatory.com

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. 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

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

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

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.

Temple University's School of Pharmacy

RA and QA Graduate Program

https://pharmacy.temple.edu/raqa

Education Opportunities

[email protected] 

1-267-468-8560

 Temple University has outstanding graduate programs in Regulatory Affairs and Quality Assurance. Our four Master of Science programs, 15 certificates, and 80+ courses are all offered online on evenings and weekends. Students may start or complete our programs during any semester (fall, spring or summer). You're welcome to take a course to advance your knowledge in a particular area (such as CMCs, High Purity Water Systems, or global pharmacovigilance), complete a certificate and then apply all of the credits towards the MS in RAQA. Our faculty are experts from the pharmaceutical, biopharmaceutical, medical device and related industries or from the U.S. FDA, so you learn real-world concepts and issues that you can immediately apply to your current position. Call us to set up an appointment to discuss your career goals or visit our website for more information.