1. Project Management

Project Management is becoming one of the most crucial activities for successful execution of a project in a timely manner to ensure that the product reaches the market on time to reap the maximum advantage. In case of Pharmaceutical project management, it additionally requires deep knowledge of the subject atter in order to ensure that quality documents are generated from the initial stage of the project itself.

Our team of technical and management experts works closely within the teams to manage the activities using most modern management techniques to ensure timely completion of project as per the committed timelines. We offer a dedicated project manager for each project/client who is easily accessible to our clients to share the real time information on on-going activities for each project.

This in large helps organization to save a huge cost in terms of completion of time bound activities, stage wise human resources allocation and have real time information on activities on-going for a project.

2. Dossier compilation, submission and maintenance of product life cycle

Our team of Technical subject experts can help you build a quality dossier with the timely inputs and review of documents which are generated from the time of product development.

We provide below services:

  • 1. Review of DMF
  • 2. Dossier compilation in CTD format (Module 1-5)
  • 3. We will review the product at different stages of its product development and can suggest if any additional data is required to be generated to make our application more robust in terms of as per current agency guidelines and requirements.
  • 4. We also can perform due diligence on your dossier to amend it as per current deficiency trend both general and product specific.
  • 5. We can help you strategize certain amendments to the ANDA which can help you reduce the overall cost of product.
  • 6. We also can help you manage the product life cycle with timely update on current requirements from the agency without the commercial supply being impacted.
3. Develop regulatory strategies to make certain foreseeable and unforeseeable changes which can help remain compliant with agency expectations in terms of quality, safety and efficacy.