We help you navigate the regulatory pathway
The regulatory team at Spectrum Research provides expertise in all phases of medical device, drug, and combination product development. For companies that do not have their own regulatory division or expert, we can fill that gap with our experts to ensure that you meet critical regulatory requirements. We are able to evaluate client’s regulatory strategies and generate a plan for helping them reach their strategic timelines in the most efficient and cost-effective manner. If you need further assistance beyond the regulatory pathway to include clinical trial design and operations, we have experienced staff to fill that need as well.
Our expertise and responsiveness makes certain that our clients are compliant with necessary regulatory requirements in a timely fashion to ensure success.
The team at Spectrum has the education and experience to assist with all of your regulatory requirements. The team consists of regulatory specialists, clinical researchers, epidemiologists, statisticians, database developers/managers, and clinicians with the ability to provide:
- Regulatory guidance for selecting the appropriate pathway for obtaining clearance/approval through the Food and Drug Administration
- Assistance with designing preclinical and clinical development plans
- Evaluation and development of Standard Operating Procedures (SOPs) for manufacturers, sponsors, and the conduct of clinical trials that follow necessary Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines
- Quality assurance auditing of sponsors and clinical trial sites
- Post-marketing surveillance, including identifying and summarizing safety and effectiveness data on the client’s product
- Representation of clients with the Food and Drug Administration
- Advice and assimilation of submission packets for:
- Investigational Device Exemption (IDE)
- Pre-market notification 510(k)
- Pre-Market Approval (PMA)
- Investigational New Drug (IND) / New Drug Application (NDA)
- Expertise in these areas:
- Orthopedics - including spine and trauma research
- Physical medicine and rehabilitation
- Diagnostic testing
- Dental implantology
- Anesthesia and pain management - Adults and pediatrics
- Drug delivery systems
Important resources:
Food and Drug Administration – Center for Devices and Radiologic Health (CDRH)
http://www.fda.gov/cdrh/index.html
Food and Drug Administration – Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder/
Food and Drug Administration – Office of Combination Products (OCP)
http://www.fda.gov/oc/combination/
International Conference on Harmonization (ICH) – Guidance for Industry: E6 Good Clinical Practice – Consolidated Guidance
http://www.fda.gov/cder/guidance/959fnl.pdf
Good Manufacturing Practices (GMP) / Quality System (QS) Regulation
http://www.fda.gov/cdrh/devadvice/32.html |
