WELCOME TO MEDEXCEL MIDDLE EAST
WELCOME TO MEDEXCEL MIDDLE EAST
MedExcel is a global regulatory and technical specialist that provides end-to-end regulatory and compliance services across lifecycle management from product development to registration and post approval compliance.
We have a proven record of successfully navigating the evolving regulatory environment across a wide range of innovative therapeutics for quality, speedy, cost-effective approvals.
Our regulatory strategy will determine the path, cost and time-to-market of your product across multiple geographies, all of which have commercial impacts. MedExcel can support with important regulatory and commercial advantages to sponsors.
MedExcel can provide expertise and solutions with the following functional services:
Developing a regulatory strategy that considers the many global challenges involved whilst delivering on your objectives is critical to the commercial success of your product.
Planning should start early in development, with continual monitoring of key milestones, data, decision points, regulatory landscapes, with any adaption as necessary, to ensure regulatory success.
Our regulatory intelligence professionals have access to relevant regulatory agencies and have the expertise to summarize and assess global regulatory intelligence to ensure submissions are compliant with evolving regional and local requirements, reducing the impact of re-work on budgets and timelines.
The MedExcel technical and medical writing team is uniquely qualified to help you collate, organize, write, edit, and create an extensive range of medical and scientific regulatory documentation required to support product development & Life Cycle management. Team MedExcel has the expertise and experience to support dossier submissions across the globe in various formats (eCTD, CTD, NeeS, national, ASEAN etc.)
MedExcel provides end to end services on the labelling requirement that includes Art work and Due Diligence of existing labels for regulatory compliance. MedExcel supports in preparation of new labels for Clinical trials, Medical devices, Food & dietary supplements & finished formulations labels, in accordance with the Global & regional requirements.
The effective supervision, compilation and submission of electronic dossiers is a complex process. The submissions team at MedExcel is equipped with comprehensive knowledge of the evolving global Regulatory guidelines and has experience with review and gap analysis of regulatory documents, medical and technical writing, along with the relevant software knowledge in publishing and submissions leading to quality, speedy approvals of regulatory compliant dossiers.
The initial approvals secured for market access is invaluable to the Biopharmaceutical Company and its investors. Maintaining post approval regulatory compliances is critical to retain the product in the market with a competitive label claim throughout its life cycle and has value for in and out licensing opportunities.
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