We are a team of knowledgeable and experienced regulatory affairs, clinical affairs, and quality system professionals eager and capable to help with advancing your medical device, biologic, in vitro diagnostic, pharmaceutical and combination products from conception to markets through the total life cycle.
Our areas of expertise include:
• Regulatory strategy (domestic and international), submission preparation and filing with US and
worldwide Regulatory Authorities.
• Clinical trials strategy and planning, management of clinical trials and analysis of results.
• Quality system design, development, implementation and maintenance.
• US and worldwide Regulatory Authorities relations and crisis management.
• Total or selected Regulatory Affairs or Clinical Affairs Outsourcing, virtual Regulatory or Clinical Affairs
Departments.
• Health Economics Outcomes Research supported by market access modeling, budget impact modeling,
evidence generation (epidemiological research, registries, supportive and historical clinical research), global value dossier development and reimbursement dossier submissions.
Please, contact us:
Irina Kulinets, PhD, RAC, CQE
617-823-0603
ikul@comcast.net
Company Details
- Employees
- 3
- Founded
- -
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- regulatoryclinical.com
R & C Consulting Group Llc Questions
R & C Consulting Group Llc's website is regulatoryclinical.com
R & C Consulting Group Llc's LinkedIn profile is https://www.linkedin.com/company/r&c-consulting-group
R & C Consulting Group Llc has
3 employees.
View email and phone details for 3
employees at R & C Consulting Group Llc.
R & C Consulting Group Llc's industry is
Biotechnology Research
R & C Consulting Group Llc's top competitors are
Phamatech, Inc,
Dx Biosamples, Llc,
Precisionmed,
Ovigenex, Llc,
Tissue For Research - Accio Biobankonline,
R&c Consulting,
C&r Consulting Group,
Rbc Consultancy Ltd,
R&g Consulting Group,
Biospecimen Industry Collaboration.
R & C Consulting Group Llc's categories are Biotechnology Research
R & C Consulting Group Llc's founding year is 2006
