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About Omar Consultants

Omar (Ophthalmic Medical and Research) Consulting Group is a North Carolina-based global medical consulting practice. Adept at unifying internal and external partners to expedite development, approval, and launch of breakthrough products in ophthalmology, hematology, metabolic diseases, and oncology; Omar Consultants are well-regarded and highly sought after individuals who are expert in strategic clinical development, medical and regulatory writing, translational research, and clinical trials. Omar consultants offer a long-standing record of achievement, career advancement, and continuous professional development.

The value we provide

  • Meticulous creation of clinical development strategies for drugs, device, and biologics
  • Collaborative management of device clinical evaluation documentation
  • Thoughtful data analysis and reporting of clinical trial results
  • Strategic preparation for meetings with regulatory agencies
Contract with Omar Consultants

Services

Omar Consulting Group was established to fill the gap between the bench and the bedside with product development support services for the pharma and medical industry.

Accomplishments

Woman Owned

Woman Owned

Woman owned

Omar Consulting began as a combination of necessity and opportunity entrepreneurship in the ophthalmic space

In the period from 2007 to 2018 the proportion of woman-owned firms in the professional/scientific/ technical services category shrank from 14% to 12%


The 5 industries in which the numer of women-owned businesses grew the most between 2007 and 2018
151%
Utilities
126%
Other Services
94%
Construction
85%
Accommodation & Food Services
70%
Admin, Support,
Waste Mgt Services
Woman Owned

Drug, Device, and Biologics Expertise

Drug, Device, and Biologics Expertise

In the period between 2007–2020 Omar Consultants has worked at the cutting edge of new entities and therapies to treat diseases with drugs, devices, and/or biologics


Drug, Device, and Biologics Clinical Development Experience
10
10
50
Preclinical
10
7
20
Phase 1
7
4
40
Phase 2
5
5
5
Phase 3
  • Biologics
  • Devices
  • Drugs
Team Experience

Team Experience

Team Experience

More than 100 Clinical Studies designed since 2005

Fields:

  • Ophthalmology
  • Oncology
  • Gastrointestinal
  • Metabolic diseases
  • Medical devices
Disease and therapeutic areas:
  • Oncology 7%
  • Metabolic and GI 10%
  • Device 23%
  • Ophthalmology 60%
Regulatory Agency Interactions

Regulatory Agency Interactions

Regulatory Agency Interactions

FDA

FDA (Food and drug administration): Type A, Type B , and Type C meetings; medical device clinical reports

Health Canada

Health Canada (Government of Canada): Preclinical trial application (preCTA), scientific advice meetings, consultations

EMEA

EMEA (European Medicines Agency): Consolidating ICH and FDA guidelines, medical device reports

  • Meetings
ARVO B2B Meeting

May 20-21, 2021
Nuts and Bolts: meeting you where you are

  • Meetings

Association Ocular Pharmacology and Therapeutics

XV Biennial Meeting (virtual)
March 4-7, 2021

Interests

Regulatory Agency Interactions
Regulatory Agency
Interactions
Board Service
Board Service
Strategic Clinical Development
Strategic Clinical
Development
Clinical Trials
Clinical Trials
Women In Ophthalmology
Women In
Ophthalmology
Advancement of Women and Girls in Science
Advancement of Women
and Girls in Science

Recent Posts

Regulatory
March 19, 2024

Regulatory

Data information and disclosurePart 3 Author: Dr. Cheryl L. Rowe-Rendleman Some exciting new changes were announced in 2023 that affect both drugs and Biologics. In the United States, “biologics”... read more
Conducting Clinical Trials
November 30, 2023

Conducting Clinical Trials

Part 2Author: Dr. Cheryl L. Rowe-Rendleman In the United States, “biological products” are subject to a different premarket pathway and differing intellectual property protections than products regulated as “drugs”.... read more