Tailored Services
Regulatory Affairs:
FWQRC provides a wide spectrum of regulatory and compliance expertise with a team of experts with decades of experience. The team ensures that each development project meets the requirements of respective regulatory standards including QbD expectations.
- Dossier preparations (CTD and eCTD)
- Filing of DMF with USFDA, EMEA ( National procedure, Centralized, De-centralized, Mutual recognition Procedures.)
- Filing of DMF for ROW Market
- Addressing the DMF deficiencies (Customer and Regulatory Queries)
- Drug License Filing with CDSCO, DCGI
- Risk assessment for Elemental Impurities
- Risk assessment for Genotoxic Impurities
- GAP analysis for regulatory filings
- Classification of Medical Devices
- Identifying the appropriate premarketing submission pathway
- Compilation and review of PMA, PMN, HDE applications in the specified formats
- Submission of application with relevant regulators to register the establishment & list the medical devices
- Post market regulation & processes
Quality Assurance:
Our Quality Assurance team assures API sourcing and development through cGMP system. The team is comprising of experts with certifications from ISQSH, ISO, IRCA.
- QA systems
- Quality Manual
- Document management system
- Compliance management
- Self inspection
- Review and evaluation of plant (QA, QC, RA, ARND, EHS) data
- Conducts training programs based on the industrial needs
- GAP analysis / Risk Assessment / CAPA
- Conducting third party vendor audit
- Preparation of responses to the audit observations
- Implementation of Standard operating procedures in line with current guidelines
- Root cause analysis for the deviations, OOS and Customer complaints
Quality Control:
FWQRC provides services like method development, method validation and onsite laboratory operation and training services for a variety of projects regardless of the complexity involved in the project.
- Analytical method development
- Analytical method validation (As per ANVISA, ICH, FDA) requirements
- Analyst Qualification
- Establishing ADE / PDE Values during the equipment cleaning process
- IFRA Certification
- IFRA Allergen Certification