Insight Pharma

Regulatory Affairs & Compliance

The pharmaceutical and life sciences industry is among the most heavily regulated in the world and non-compliance of regulatory requirement is an expense that no healthcare company can afford. Companies are facing unprecedented compliance challenges, and the close regulatory scrutiny to which they are subject is unlikely to abate anytime soon. Further, companies are facing emerging risks as they adapt their business to changing regulatory and market-driven pressures, including globalization, the advancement of technology, and the changing expectations of stakeholders.

An effective compliance management is needed more than ever in pharmaceutical and life sciences industry. New information systems, strategies and processes to manage compliance are rapidly evolving which need to be updated and implemented in the company system. IBRSoluTions offers a comprehensive range of tailored services to meet the regulatory affairs and compliance services helping healthcare companies around the world augment their internal capabilities to prepare for, execute and address compliance-related observations and deficiencies, thus mitigating their regulatory risk.

We help our clients to avoid issues with regulatory agencies and implement the necessary quality systems to meet the regulations. We work with our clients to design and implement effective and efficient processes that assure continued compliance. From complex compliance services to simple submission filing assistance, our portfolio of offerings enables us to create a truly customized solution to each client’s unique regulatory affairs challenges, whether dealing with FDA regulations or regulatory agencies in regulated or semi regulated markets. Our regulatory affair & compliance services are for pharmaceuticals, biotech, consumer healthcare, medical devices and generics sectors.

IBRSoluTions provides the following Regulatory Affairs & Compliance Services:

Regulatory Affairs & Compliance Services
  • Regulatory Operation

  • Regulatory Strategy

  • Patent Certification

  • Exclusivity Statement

  • Drug Product Labeling

  • DMF & EDMF Filings & Updates

  • Paragraph IV Filings & Updates

Regulatory Operation

  • Medical device, healthcare and pharmaceutical industries must ensure compliance with government regulations and laws relevant to their product. IBRSoluTions provides complete regulatory submission services to our client to meet regulatory requirements throughout the different stages of drug development and post approval. We help our clients:

    NDA/ANDA Submissions: Prepare, review and assemble document submissions to global regulatory authorities, including new applications, ANDA applications, registration, renewals, product listings and investigational applications.
    Regulatory Agency Interaction: Coordinate with relevant agencies to resolve issues and speed up approvals.
    Setup and implement regulatory standard operating procedures.
    Handle day-to-day regulatory operations.
    Provide expert advice on regulatory strategy.
    Post Approval Reports
    Drug Master Files (DMFs) filing & Updates
    Post approval Submission of supplements, amendments and variations applications
    License renewal applications
    Regulatory compliance reviews checking approved license information against technical documents used in manufacturing and testing of medicinal products
    Maintenance of labels and reference safety information
    Review and approval of advertising/promotional materials

Regulatory Strategy

  • Quick, effective and efficient approval of pharmaceutical products needs proper regulatory strategy. An understanding of global regulatory requirement is very much essential to cope of with growing regulatory requirement, expanding to new markets and change in business model. IBRSoluTions provides guidance and strategy to help clients understand and navigate the regulatory challenges that arise during the product development process for IND, NDA, sNDA, generics, biologics and medical devices. We help our clients to develop dossiers for all regulated, semi regulated and non-regulated markets. We help our clients:

    Developing global submission strategy
    Advising on country-specific filing strategies
    Assisting agency meetings
    Preparing and submitting applications
    Response to agency queries
    Providing issue-focused regulatory support and gap analysis
    Risk Management Planning
    Advisory Committee preparation
    Scientific Advice and Protocol Assistance
    Lifecycle management
    Input from Subject Matter Experts

Patent Certification

  • While filing a generic product for approval in USFDA, the applicant needs to address the OB listed patents for the products. We provide drafting and reviewing the patent certification and section viii statement for various generic and 505(b)(2) type filing.

Exclusivity Statement

  • While filing a generic product for approval in USFDA, the applicant needs to address the exclusivity for the products. We provide drafting and reviewing the exclusivity statement for various generic and 505(b)(2) type filing.

Drug Product Labeling

  • Labeling is a critical aspect of product life cycle management and label includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug or medical device . With the complex approval procedure for products, content and size of labeling documents in the industry are also strictly regulated. Even after introducing the product into the market, these documents need to be continuously updated. For approval of a generic drug product, the generic drug's labeling must be essentially the same as that of the approved drug product but the current FDA labeling guidelines allows certain changes in the generic label.

    IBRSoluTions gives foolproof service for drafting and reviewing of NDA, generics as well medical devices product label to help our clients in preparing label for easy approval of their products. We help our clients from initiation of the change request for labeling (immediate packaging text and PIL), to implementation of the same for various regulated markets like the US and EU and emerging markets like Latin America, Asia, CIS, and Middle East. The team has expertise in leading the creation of high quality documents supporting changes to the CDS, including the preparation of responses to labeling-related Health Authority queries. We provide the following global label development activities:
    Creating and maintaining regulatory compliant and up to date global labeling documents (CDS, SmPC, PIL and labeling texts)
    Labeling updates and amendments submission
    Preparation of labeling comparisons (for generic product labeling submissions)
    Artwork Preparation (label, secondary packaging like carton, foil, package insert, etc.)
    Structured Product Labeling (SPL)
    Labeling updates and amendments
    Product Information Leaflets (PIL)/Medication guide
    Country specific conversion of Labeling
    Company Core Data Sheet (CCDS)
    Labeling Justification Document (LJD)

DMF & EDMF Filings & Updates

  • The Drug Master File (DMF) is a document submitted by pharmaceutical manufacturers solely at their discretion to the appropriate regulatory authority in the intended drug market. The DMF holder either can incorporate the DMF data as a reference in its own NDA or ANDA products or permit others to rely on its DMF information to support their NDA or ANDA. Drug Master Files provide valuable information to help sourcing active ingredients and keep an eye on competitors. We provide the DMF & EDMF filing details and updates to help our clients for evaluating the best sources for their active ingredients and also to keep eye on competitors.

Paragraph IV Filings & Updates

  • Paragraph IV (Para IV) is a statutory concept related to the US drug regulatory and patent system brought in for balancing the business interests of pioneers and generic drug manufactures, and is primarily credited for the development of the US generic drug industry. Though other types of certification like Para I, II and III can be filed for approval of any generic product, Para IV is having its own advantage like small number of generic players due to high R&D cost for preparing a non-infringing formulation as well as high litigation cost to challenge the patent. The details of the Paragraph IV filers like who are the filers, number of filers, date of filing etc. allow easy determination of who the first movers are for a particular generic product in the US. We provide detailed Para IV filing services which includes from filing a certification till launch of the product in the market. We update every steps of the Para IV filing with respect to a product as per the requirement of our clients.

Copyright © 2019 IBRSoluTions. All rights reserved Hand crafted by Techno source IT Solutions