Morula Health
Email: info@morulahealth.com
Website: http://www.morulahealth.com/
Phone: +44 (0)20 7691 1122
Skills and Services:
We offer professional medical writing services that are tailored to meet the specific needs of biotech, pharmaceutical, and medical device companies worldwide. We also provide additional supporting services to offer integrated solutions, such as QC and publishing.
Our medical writing services include:
Regulatory: IND/NDA/BLA, Fast Track Designations, Regulatory Responses, Pediatric Investigation Plans (PIP), and more.
Clinical: Clinical Trial Protocols (CTP), Clinical Study Reports (CSR), Investigator's Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), and more.
Nonclinical: Nonclinical reports, Meeting Request Letters, Briefing Documents, CTD Module 4, and more.
Safety: Development Safety Update Reports (DSUR), Safety Narratives, Periodic Safety Update Reports (PSUR), and more.
Medical Devices: Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Clinical Investigation Plans, and more.
Medical Communications: Posters, Manuscripts, Abstracts, Plain Language Summaries, and more.
Expertise:
When we assign our medical writers to projects, we follow specific and relevant criteria:
Disease & Therapeutics - Experienced writers with a background in various clinical, regulatory, and medical writing settings
Technology - Extensive experience across biologics, cell and gene therapy, small molecules, vaccines, diagnostics, and all classes of medical devices.
Document- Writers are assigned based on their experience completing the required documents. They have expertise in more than 80 documents.
Regulatory Agency - An in-depth understanding of how to write documents for submission to the FDA, EMA, NMPA, PMDA, MHRA, Health Canada and other regulatory agencies globally.
Customer - We are experienced and regularly work with large and small pharmaceutical and biotechnology companies; we understand their unique requirements and tailor our services accordingly.
We don't assign writers just based on their availability. We assign them based on their expertise, as well as their genuine interest and passion for the project. We believe this leads to the best outcomes for both the writer and the client.
Other Information:
We provide additional supporting services i.e. QC and publishing to deliver an integrated solution for our clients, reducing the burden of regulatory submissions and clinical trial documentation.
If you have additional questions, please visit our website www.morulahealth.com and contact us for more information.