top of page
Committed medical writers with extensive expertise
We constitute a team of committed medical writers with extensive expertise in medical and scientific writing spanning diverse therapeutic areas and various classes of molecules. Our proficiency covers non-clinical, clinical, and quality aspects. At My Pharma, we adopt a flexible approach. Our consultants are adept at composing regulatory submissions independently, collaborating with clients in document creation, and offering strategic support and review for clients who prefer to author their own medical and scientific documents.
Documents for Global Submissions
The success of the global marketing application process is significantly impacted by the quality of the documents included in the application. At MY Pharma, we offer assistance in generating various components of the global marketing application dossier, including:
Module 1 and Labeling and Risk Management Plans
Module 2 Summaries and Overviews
Module 3 Quality Dossier
Our expertise ensures the production of comprehensive and high-quality documents crucial for a successful global marketing application.
Clinical Study Reports
ICH E3 compliant clinical study reports are indispensable for any global Marketing Application. Our seasoned medical writers at MY Pharma specialize in crafting high-quality clinical study reports that adhere fully to ICH E3 standards. We provide comprehensive assistance with various aspects of a clinical study report, including:
-
Appendix assembly
-
Lay language summaries
-
Narratives
Our commitment is to deliver meticulously prepared clinical study reports that meet the stringent requirements of ICH E3, contributing to the overall success of your Marketing Application.
Clinical Trial Documents
The success of regulatory and ethics submissions, as well as the overall conduct of a clinical trial, is significantly influenced by the quality of the supporting Clinical Trial Documents. Our team of experienced medical and scientific writers is well-equipped to deliver high-quality documents to support your clinical trials.
This includes:
-
Clinical Study Protocols (CSPs)
-
Investigator Brochures (IBs), including Reference Safety Information (RSI)
-
Investigational New Drug Applications (INDs)
-
Investigational Medicinal Product Dossiers (IMPDs)
-
Patient Information Sheets (PIS) and Informed Consent Forms (ICF
SOPs and Controlled Documents
In a highly regulated industry, the development of clear Standard Operating Procedures (SOPs) and procedures is of paramount importance. Our team specializes in authoring Quality Management System documents to ensure your company's compliance with key aspects of Good Practice (GXP).
.jpeg)
About
About MY Pharma Consulting
MY Pharma Consulting offers regulatory affairs, pharmacovigilance, compliance, and quality services aimed at assisting pharmaceutical and biotechnology firms in navigating the complex regulated landscape. We support our clients with acquiring and upholding medicinal product licenses throughout every phase of a product's existence.
bottom of page