The Trusted Experience and Professional Service
We provide professional services to our pharmaceutical customers
Regcellent keep up-to-date on the latest information, data, laws and regulations of FDA
Feel the comfort of gaining improved confidence in sustaining quality and regulatory compliance.
If you are looking for help concerning FDA regulatory matters, you are at the right place.
Regcellent is a one-stop solution for all FDA Regulatory services ranging from DMF, IND, NDA and ANDA Filings to Establishment Registration and Mock CGMP Inspections

Why Regcellent?

  • Technical Writing Skills:

    The current emphasis on "knowledge-based" rather than data-based product filings under the aegis of "Quality by Design" makes it imperative that new product filings or updates for existing products...

  • Trusted Expertise:

    Regcellent consulting team includes only highly experienced consultants who have a solid knowledge base, strong FDA net-working base, and technical expertise that comes only from decades of hard-won experience...

  • Effective Time Dynamics:

    Regcellent provides solutions to solve problems correctly the first time-helping ensure that you achieve your desired outcomes quickly and efficiently...

  • Repeating Client base:

    Because of the simple reason Regcellent consistently delivers thoughtful, effective consulting solutions, Clients repeatedly engage...


Our Services

  • Establishment Registration
  • Labeler Code and Drug Listing
  • US Agent Services for both DMF and ANDAs
  • SPL (Label) creation and uploading Services
  • Full writing of eCTD ANDA ESG filings
  • Conversion of CTD ANDA to eCTD ANDA ESG filings
  • Converting DMF's to eCTD ESG filings
  • Process Validation services (IQ, OQ, and PQ)
  • cGMP Mock Audit Services and pre-approval inspections
  • Conducting due diligence audits

About us

  • The primary Goal of any pharmaceutical company are the new products they have in development that have the promise of making a positive difference to patients and providing revenue for the company. Getting to the approval of these products will require diligence and focus in research efforts, patience with the reporting of data and the ability to work effectively and cooperatively with the agency regulatory personnel.

    Regcellent Consulting LLC specializes in US Food and Drug Administration (USFDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical firms comply with applicable laws and regulations.

Our Mission

With the great understanding of FDA regulations and best interest of clients, provide best possible regulatory suggestions and service in an ethical, timely, and cost effective way with closely working client relation dynamics.