Providing Strategic Medical Writing Services for All Your Clinical Needs
Minola Scientific provides expert Clinical Research & Medical Writing consulting services across the medical device and pharmaceutical industries. Our highly experienced team has expertise in a wide range of fields.
Overwhelmed by the EU MDR transition or an FDA investigational new drug submission? Minola Scientific can help.
MEDICAL DEVICES
Services Include:
Clinical Evaluation Plans & Reports
CE Memos & Addendums
Clinical Study Protocols & Reports
Summary of Safety & Clinical Performance
Technical Documentation
Regulatory Documentation
Post-market Surveillance Plans, Reports, and Update Reports
MDD to MDR Transition Gap Analyses
GSPR Checklists
Peer-reviewed Publication Drafting, Editing, & Submissions
White Papers
Advertising & Copyediting
Investigator’s Brochures
FDA Submissions (CTDs, INDs, and BLAs)
The team at Minola Scientific has vast clinical and regulatory experience in a variety of Class I, Class II, and Class III devices across a wide array of industries, including but not limited to:
Craniomaxillofacial surgery and dental implants
Neurology and neuropharmaceutical
EEG and neuroimaging
Neuromodulation
Opthalmology
Oncology
Orthopedics
Trauma
Guided and robotic surgery
Surgical instruments
Dermal and transoral fillers
Peripheral nerve injury repair
Peripheral intravenous catheters
Wound care
Urology
PHARMACEUTICALS
Services Include:
Clinical Research Study Protocols & Reports
Technical Documentation
Regulatory Documentation
Peer-reviewed Publication Drafting, Editing, & Submissions
White Papers
Advertising & Copyediting
Investigator’s Brochures
FDA Submissions (CTDs and INDs)
Nonclinical modules
The team at Minola Scientific has extensive clinical and regulatory experience in preclinical, Phase I, and Phase II trials across a wide variety of industries, including but not limited to:
Oncology
Vaccines
Infectious disease
Neurology and neuropharmaceutical