Why Regcellent?

When it comes to quality of regulatory filings and FDA compliance issues, Regcellent has helped pharmaceutical organizations in making quality regulatory filings, obtaining timely approvals and sustaining cGMP compliance of manufacturing facilities.
  • 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 are written to reassure the Reviewer that the Company understands the product and process within QbD acceptance bracket and precisely that is where Regcellent technical writing skills makes a difference..

    The compilation of high-quality application is a particular skill offered by Regcellent that has been developed over many years’ dialogue with Regulatory Agencies, including the construction of Expert Reports and Quality Overall Summaries (QoS).

  • 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. We believe trusted expertise transforms into reputation.

  • Effective Time Dynamics:

    Regcellent provides solutions to solve problems correctly the first time-helping ensure that you achieve your desired outcomes quickly and efficiently. We not only assess what needs to be done; we also offer the scientific and technical know-how to guide you through the required steps on the entire process of regulatory filings and cGMP compliance.

  • Repeating Client base:

    Because of the simple reason Regcellent consistently delivers thoughtful, effective consulting solutions, Clients repeatedly engage Regcellent and provide referrals of others concerning their cGMP compliance and regulatory filing issues.