Scientific/Technical Writing & Manuscripts
MBPharmaco Consulting excels in the domain of Regulatory Writing for submissions to help avoid delays in the regulatory approval process.
The team has developed numerous documents for various submissions worldwide and is well-versed in handling submissions for the US FDA, EMEA, MHRA, and other regulated and semi-regulated countries.
- Developing and reviewing documents necessary for regulatory submissions, such as protocols, Investigator’s Brochures, and drug labels
- Adapting and translating documents to meet local requirements
- Preparing and reviewing submission packages
- Completing clinical trial application forms
- Submitting clinical trial applications to the Medicines & Healthcare Products Regulatory Agency (MHRA)
- Addressing clarification requests and answering questions from the MHRA
- Conducting Phase I-IV clinical trials with drugs or medical devices in a wide range of therapeutic areas, including oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious diseases, and respiratory diseases, among others.
Our team is also flexible and can adapt to client-specific processes and templates for document development. We align experts and team members based on project-specific requirements, ensuring better time management through an efficient transition to project completion.
Contact us to learn more about how our services can benefit your organisation.
