Clinical Research

Pharmacovigilance and Drug Safety Expertise

Regulatory Affairs

 

Regulatory Affairs

Regulatory Affairs and Product Development Consulting

Delight Consulting Services Business Services is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry. Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. Biopharmaceutical products and biomarkers are our particular speciality. Delight Consulting Services has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond.
Our expertise covers a wide range of products (around 400 products to date), including products of recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, somatic cell therapy and tissue-engineered products. Delight Consulting Services is also competent to consult on innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. Last, but not least, the Delight Consulting Services team includes specialists for companion diagnostics and biomarkers, offering dedicated services in this cutting edge field.
Our specialized international team of more than 30 professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit. Delight Consulting Services has sophisticated and well-equipped office facilities, currently in India location, with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group. Please use our 'contact us' form for any further information you may require. The Delight Consulting Services team would value the opportunity to present our capabilities and expertise in a personal meeting.


Submissions

Delight Consulting Services recognises that a regulatory submission is a means to an end, and not an end in itself. The aim is a successful marketing authorisation, and this requires efficient and appropriate responses to agency questions and objections. Our team is often called in to help at this crucial stage of the review process, providing input on the interpretation of questions, understanding the additional documentation that will be required and the way it needs to be presented in a response package.
The India, US and European regulatory procedures for biopharmaceutical products differ significantly with respect to responding to questions and objections on the part of the assessors. In the US, where the review already starts at the IND stage, and proceeds through the BLA, the process is somewhat iterative. By contrast, in the EU, the Centralised Procedure for biotech products offers just one main opportunity for a company to satisfy questions from the CHMP. In order to provide a satisfactory response package as the absolute prerequisite for a subsequent marketing authorisation, the company must first understand the questions, the additional data that may be requested, the level of detail that is required, and the manner in which this needs to be presented.
Delight Consulting Services has considerable experience in the interpretation of consolidated lists of questions and objections, which should be analysed by a company in the light of the assessment reports that are provided by the rapporteur and co-rapporteur. It also needs to be appreciated that the time available to the assessors to review the company’s response package is limited. Hence, in order to achieve success, the responses must be compiled in a way that affords efficient review by the regulator. This requires clarity in the approach and a clear presentation of the data, in order to satisfy the objection, as well as justifying the company’s position on the issue. Here, Delight Consulting Services ’s expertise can be invaluable


Post Approval

It should be apparent that the Delight Consulting Services team can support a client’s efforts from early stage development of a biopharmaceutical product, through the entire regulatory process to a successful marketing authorisation. However, our services do not necessarily stop at that point. Once approval has been obtained, there is usually a need for variations on the original marketing authorisation, introducing process scale-up, changing details in the product characteristics, adding new dosage strengths of the product, or new presentations, introducing new manufacturing facilities, applying for additional indications, and so forth. Moreover, a marketing authorisation requires continuous monitoring, in order to ensure that the conditions of the approval are being met, for example in the area of responding to ongoing questions that were not answered pre-approval. In some cases, we have continued to work on products that were originally approved with our involvement more than 18 years ago. In such cases, Delight Consulting Services provides continuity in understanding how the product and the process has evolved over that period of time, providing input on the strategy and timing of future variations, and supporting the client in obtaining agreement with the relevant regulatory authorities on the strategy for changes.
Our services relating to post-approval issues include: Development of strategies for post-approval variations to the marketing authorisation, notably:

  • changes to manufacturing facilities or the process
  • changes to product characteristics or presentation of the product
  • extensions of shelf-life
  • introduction of additional indications to the original marketing authorisation

Monitoring of post-approval commitments and responses to ongoing questions Organisation of post-approval meetings with regulators to address future issues in product development Discussion of variation strategies and timing with regulatory authorities Compilation and submission of responses to ongoing commitments, and variation dossiers

   
   

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