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. We specialize in traumatic injury, neurodegenerative disease, infectious disease and late stage oncology, and are highly experienced 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)

  • Modules 2 and 5

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:

  • Peripheral nerve injury

  • Traumatic injury

  • EEG and neuroimaging

  • Neuromodulation

  • Opthalmology

  • Orthopedics

  • Craniomaxillofacial surgery and dental implants

  • Guided and robotic surgery

  • Surgical instruments

  • Dermal and transoral fillers

  • 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, NDAs and INDs)

  • Modules 2 and 5

Minola Scientific has extensive clinical and regulatory experience in preclinical, Phase I, Phase II and Phase III trials across a wide variety of industries, including but not limited to:

  • Oncology

  • Neuropharmaceutical and neurodegenerative disease

  • Vaccines

  • Infectious disease

Our mission at Minola Scientific is to provide expert clinical research and medical writing services. With over a decade of experience in the medical device, clinical research, pharmaceutical, academic research, and non-profit industries, Minola Scientific creates a partnership with our clients in order to continually deliver excellence.

No matter how small or large your team is, Minola Scientific can help.