IDMP RO (Resource Outsourcing) Services

Identification of medicinal products is a complex regulation to implement as it involves not just regulatory affairs but all the major departments of a company namely manufacturing, safety, financial, quality and others.

Pharma companies are already engaged in several activities related with Regulatory affairs and dealing with multiple regulatory bodies and for various reasons namely market authorization, clinical trials, and many others. In fact each and every department is overloaded with tons of internal work pertaining to new and established medicines, Quality, safety, operations, supply Chain.

ISO IDMP requires data to be submitted in same format across all the divisions and departments. Patient safety is paramount in consideration in ISO IDMP legislation and in order to achieve this it is important that all the medicine information should seamlessly be processed when required, irrespective of different manufacturing company or location.

Challenges:
  • Manpower resource paucity due to sudden demand in expert resources to plan out strategy or augment existing team for expert advisory.
  • In order to submit data to agency first of all correct data in correct format must be there and that is a big challenge as data is usually scattered in different silos.
  • Majority of relevant data is scattered in multiple documents in various places not necessarily stored in databases.
Solution:
  • Makrocare understands the gravity and enormity of regulation as well as understands the level of preparedness required at the MAH’s end. Our IDMP-RO service is designed to help organization without disturbing their existing set up and helping them out with utmost dedication and proficiency.
  • We have team of trained data experts who has expertise in searching data from various resources namely excel files, pdf documents, paper files and other legacy systems. We will dedicate a team as per your requirement for period of time and they will search, clean and format the data as per the requirement. We have large capacity currently and can expand it as required.
Advantage:
  • Productivity enhancement: Our solution helps achieving enhanced productivity by employing highly skilled resources and processes. We make sure that work is done well within the timeline without any error or delay.
  • Optimum utilization of resources: Resource management is challenging task as it affects every single aspect of business, keeping this important piece in mind we have developed solution which fully utilizes resource capacities.
  • Focus on core business area: The reason why our clients like work with us is that we help them focus on their core areas where we take full responsibility of managing secondary tasks.
  • Value for money: we make sure that our client’s business stay thrived and profitable and to achieve this we focus on saving every single penny by providing highly cost effective solution.
  • Expanded agility: Doing more in less time is the need of the day. Our solutions are designed to help clients achieving results in smaller turnaround time.
  • Technology enrichment: We strive to develop solutions which complement and augment client’s capabilities. Our solution plays an important role in boosting your technical capability and resulting in overall process improvement.

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