Regulatory Services
LYF Research helps the clients to plan and execute the regulatory requirements from the early stages of product development through to marketing authorizations.
Dossier/submission preparation or review and filing
- Pre-meeting packages
- Investigational New Drugs (INDs)
- Clinical Trial Applications (CTAs)
- Investigational Device Exemption (IDE)
- Post-filing submissions
- New Drug Application (NDA)
- New Drug Submission (NDS) (Canada)
- Marketing Authorization Application (MAA) (EMeA)
- Biological License Application (BLA)
- 510(K) is a premarket submission
Pre-market Approval (PMA) filings (US, Canada, EU)
- Submission preparation to other worldwide agencies in European countries, South America, Australia, and Asia
- Development of regulatory plan
As a part of our services,
- We compare and consider the international regulatory requirements for international filings.
- We assist in revision of plans as guidelines change or new treaties are formed
- We manage the development and customization of software for regulatory operations and records.
- Strong follow-up and interaction with regulatory agencies
We create and maintain liaison with regulatory agencies on regulatory; Chemistry, Manufacturing and Controls (CMC); clinical; and toxicology matters such as
- Respond to regulatory agency questions regarding:
- Regulatory classification of products across different jurisdictions
- Provide expert regulatory CMC compliance advice throughout development
- Work with Sponsors and regulatory authorities through the resolution of complex development issues
- Act as US Representative for US submissions, as EU Agent in Europe, and as Canadian Representative for Canadian submissions
- Assist with due diligence activities for investors/licensees
- Scientific and medical writing services