Global GxP & Regulatory Services for Food,Drugs,Cosmetics & Medical Device Industries
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
Our Quality Assurance team assures API sourcing and development through cGMP system. The team is comprising of experts with certifications from ISQSH, ISO, IRCA.
Document management system
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
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
Establishing ADE / PDE Values during the equipment cleaning process
The main goal of FWQRC is to provide tailored services that meet your needs and help you overcome your specific challenges for better outcomes.
FWQRC offer flexible services. You can use FWQRC team as needed with no long term commitment. This allows you a better control of your operating costs and meet your business goals in a timely manner while using FWQRC team of professionals.
We always offer you the best options to meet your goals in a timely manner while staying in your budget. We are competitive, honest and realistic. Regulatory compliance is a big job. Even if you know what you need to do, sometimes you simply don’t have enough people to get it all done. When you need extra hands, think of us as your virtual regulatory compliance team. Give some or all of your work to us and we’ll get it done.
Extra Effort and Care
Whether you are a large multinational or an early stage life science company, FWQRC always provide you the same level of quality and personal service. We take pride in our accountability to our clients and have a large base of repeat and long-term customers. Our senior leadership is deeply involved in day-to-day activities to ensure that our clients receive excellent and tailored services that meet their needs.
“Because FWQRC care about your success, FWQRC not only a service provider but we consider ourselves your partner who makes sure that you are and stay on the right path at the right time during the whole life cycle of your products”