Regulatory Affairs

clinical regulatory services

Regulatory Affairs

At Biosphere, we present to you a team of clinical research professionals with diverse backgrounds and vast experience in the industry.

There are several regulatory bodies who control and approve various aspects of clinical trials. Our clinical regulatory services team helps you with each and every document required to get a clearance from the regulatory bodies. Clinical trials might require you to obtain information or resources from various countries. The regulatory framework for conducting trials varies from one country to another. We have the expertise to guide you with the right information, personnel, resources and other needs that might arise during the product development process. Biosphere is well-connected to a network of experts and consultants worldwide to support clients with the necessary paperwork for successfully conducting and completing the clinical trials.

Our wide range of services for clinical trials such as medical writing, remote monitoring, pharmacovigilance, data management, etc. are also offered as an integrated solution for project sponsors. With our cross-functional expertise, we ensure that the project data is planned, created, disseminated and documented in a format that can be submission-ready for regulatory approvals.

Service Offered

  • We provide both regulatory consulting and management services for clinical trials across the globe.
  • We hand hold you through the entire drug approval process.

Benefits

  • Timely regulatory submissions leads to timely clearances at every stage of the project.
  • Appropriate documentation helps to maintain the good reputation of a sponsor and smoothens the regulatory submission process.
  • Regulatory affairs services supports in identifying and collecting all the relevant regulatory clearances so that the product can be successfully developed and launched as per market requirements.

Speak to a member of our team about our clinical and safety data services

Our expert will work with you to gain insight to your molecule, anticipated outcomes and definite trial requirements and provide a customised design best suited for your molecule.

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