Regulatory Affairs

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We are services company that encompasses innovative, cutting edge and high quality services. The company resource consists of high end professionals with proven track records in their domain of expertise.

Regulatory Affairs

As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. That triggers the need for well-defined Regulatory strategies right from the product development to life cycle management to addressing all submission requirements, and to comply with the mandatory requirements.

  • Strategic planning for a global clinical trial during development of a product
  • Strategic planning for entering various regions across the globe
  • Strategic planning to take the products approved in one region to other Regulated markets (for example, the USA to Europe or vice versa)
  • Stability study planning for all possible presentations / container closure system
  • Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route maps

Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. With a proven track record to keep abreast with global market conditions and navigating clients across through their unique Regulatory requirements, RAC stands a preferred Regulatory strategic partner for any Healthcare company.

The services we offer are as below:

  • Submission & Management of Registration Dossier;
  • Post Approval Changes;
  • License Renewal;
  • Variations Dossier Preparation & Regulatory Responses;
  • Transfers;
  • Site Transfers, Variations;
  • Variations to the original variation.

End to End Dossier Life-Cycle Management

The Regulatory requirements vary at a global level, with every region, every Health Authority (HA) and every product category. Be it data requirements and integration, clinical trial phases and methodology, device classifications and Unique Device Identification (UDI) requirements, ingredient assessment and formulation reviews, data publishing and submission formats (either electronic or paper), every single procedure is unique and aligned with region-specific requirements. Given the intricacies of regional/local requirements, it is indeed a complex situation for manufacturers to ensure that they adopt the right path.

Adding to these global and regional procedural complexities, a handful of end-to-end Regulatory service providers make the situation even more critical for manufacturers seeking in-time global expansion in a cost-effective way.

So, its better to have a service provider who has complete knowledge of the local Pharma Regulatory market space along with some knowledge of a customizable suite of Regulatory services spanning across strategy to submissions, rather than a regular service provider who has expertise in only a single Regulatory function, and might incur huge costs for the drug manufacturer.

Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, RAC offers a full spectrum of end-to-end Regulatory services that span across strategy to submissions and lifecycle maintenance.

End to End Product Life-Cycle Management

The Life Sciences industry is developing and is anticipated to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning more protective of increasing healthcare concerns. Along with tending to the healthcare needs and adjusting with the market situation, the pharma, biotech, cosmetics, medical devices and healthcare organizations shouldn’t only innovate new compliant products, but also ensure that they are accessible across the globe with stringent safety and efficacy measures. To enable products to reach the global market or to expand businesses to other regions/markets, what is required may be a clear-cut outline product specifications along with the regional Regulatory requirements of targeted countries.

Effective management of the product lifecycle seems out of reach for many pharmaceutical companies as they struggle with fragmented technology and processes. These operational challenges result in limited visibility and collaboration across the enterprise on activities related to regulatory affairs and often lead to delayed time to market, escalating costs, and compliance risks. Success requires reimagining end-to-end regulatory affairs processes and related organizational transformation. An agile, process-centric technology layer that complements existing systems of record can help accelerate and sustain the transformation.

RAC provides the global life sciences industry with consulting services and solutions to support regulatory affairs operations and strategy. We specialize in helping our clients reduce time to market and cost by providing flexible, information-based services. With regulatory expertise that spans all types of products, our global regulatory consultants apply up to date robust regulatory intelligence to support product lifecycle management and submission strategies. Benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered cost and ongoing regulatory compliance.

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