Regulatory Services

Our regulatory services is a combination of regulatory strategy and operations. Our approach encompasses a Go-to-market strategy along with robust proof of details that results in a submission package of high quality and compliance.

Regulatory Strategy

  • Complete Regulatory Advice
  • Scientific Advice
  • Negotiation with Regulators

Regulatory Operations

  • Drafting Briefing Books and Dossiers
  • Query Management

Scientific and Regulatory Writing

IBPS also offers services in Scientific & Regulatory Writing. Drawing strongly from the fundamentals of “Proof of Details”, our expert team of scientific writers provide high quality documentation compliant with ICH and regulatory requirements for your program. We also ensure timely delivery along with completeness of the documentation. We cover:

TURNING AROUND A DISTRESSED ASSET

Client acquired rights to a potential blockbuster asset with intention of re-commercializing the previously approved brand name. This product was critical for the company’s commercial strategy. Client had invested over $ 100 Mn in the product and had filed for approval in 2020 but was turned down by FDA over concerns related to chemistry, manufacturing and controls sections. IBPS was brought on board and in record time successfully supported the company in addressing FDA concerns and enabled the company to get approval of the product. The client also expressed their appreciation towards IBPS’s expertise and dedication to the project.