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I will develop pharmaceutical formulations and analytical testing
PhD Pharmacist, Clinical Research Scientist and Medical Writer
I am Dr. Muhammad Arfat Yameen, a PhD-qualified scientist and clinical research professional with expertise in clinical research, clinical trial management, microbiology, pharmaceuticals, preclinical ...
About this Gig
Are you a pharmaceutical company or CRO looking for expert support in formulation development and analytical method validation for regulatory submissions?
I provide professional pharmaceutical formulation development and analytical validation services tailored for FDA, EMA, PMDA, and ICH guidelines.
SERVICES INCLUDE:
Formulation Design: excipient selection, compatibility assessment, prototype development (solid, liquid, semisolid), pre-formulation and stability screening.
Analytical Method Validation: ICH Q2(R1) compliant protocols covering specificity, linearity, accuracy, precision, and robustness. Dissolution and release testing documentation.
Regulatory Documentation: CMC summaries, drug product dossier sections (Module 3), GMP-compliant SOPs and batch records.
Stability Studies: ICH Q1A(R2) stability protocols, real-time and accelerated stability reports, shelf-life determination documentation.
WHY CHOOSE ME: PhD-level expertise in pharmaceutical sciences, FDA/EMA regulatory submission experience, GLP/GMP-compliant documentation, full confidentiality guaranteed. Message me to discuss your project.
Service type:
Analysis
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
Academic work to be done for you, is unethical since it violates most schools’ Honor Codes.
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My Portfolio
FAQ
What information do you need to start the formulation or validation project?
Please share your drug substance details, target dosage form, regulatory market (FDA/EMA/ICH), and any existing formulation or analytical data. This helps me tailor the deliverables to your submission requirements.
