mcgenome

McGenome LLC

Drugs, Biologics and Medical Devices Development, Marketing, and Regulatory Affairs

Accelerating drug development with comprehensive market strategy and regulatory affairs expertise

about us

Receive business consulting services in the field of drug development, and Medical Devices from pre-clinical, clinical, post-market surveillance and Regulatory Affairs

McGenome LLC represents experienced and accomplished pharmaceutical scientific, clinical expertise with strong track record in both drug discovery and business development including negotiation of business deals, developing and supervision of multidisciplinary teams. We have led directing successful drug discovery programs and departments and establishing external partnerships with universities and global biopharmaceutical companies.

Services

We work with all life science companies big and small to bring new strategy for growth in the face of regulatory challenges, pricing constraints, and ever-changing industry landscape. As your friend and partner, we strive to develop actionable solutions to solve your problems and address your and your stakeholder’s needs and your profit margins

Pre-Clinical, Clinical, Regulatory for Drugs, Biologics, Medical Devices and Biosimilars, and Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice in Drug Development, Audits and Meetings with the FDA and Regulatory Authorities, Electronic Document submission and Publication

Consultancy Services Provided to

Abbott Inc

Alphasights Company

Neopharm Inc

Lynk Global

Tegus: Tegus is the leading market intelligence platform for key decision - makers

Medline LP

NEC Corporation, Japan

Sumitomo Inc. Japan

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Regulatory Affairs
Consulting

McGenome can help you with compliance and regulatory challenges, guide and assist pharmaceutical, biotech, medical device and healthcare companies in the design

operation and implementation of innovative and global regulatory strategies.

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Regulatory Compliance
Consulting

McGenome consultants work closely with regulatory agencies like the FDA in the United States, TGA in Australia, MHRA in the United Kingdom, and MCC in

South Africa, to name a few. We help companies develop procedures, processes, and controls to ensure continued success.

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Medical Device Regulatory
Consulting

McGenome provides consultation to develop, market and work with regulatory agencies like the FDA in the USA, to strategize procedures, processes and controls to

ensure your success.

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Pharmaceutical Regulatory Affairs
Services:

We at McGenome, provide Regulatory affairs liaisons and manage the process of working with project teams and interacting with the regulatory

health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The FDA's Office of Regulatory Affairs (ORA) is responsible for conducting inspections of regulated products and manufacturers.

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Global Regulatory and marketing Strategic Consulting

McGenome serves in a specialized area of expertise in global regulatory and marketing consulting that provides strategic regulatory advice for effective

development of products. It serves clients around the globe—from biotech start-ups to global pharma and medical device —as well as the research, investment, and legal firms that serve them. We can help you anticipate and adapt to changes in your regulatory environment by developing strategies, structures, and processes that enable a proactive, forward-looking assessment of regulatory trends and their impacts on business models.

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Operational Services
Support

McGenome can help you in the post-marketing surveillance, the practice of monitoring the safety of a pharmaceutical drug or medical

device after it has been released on the market. It is an important part of the science of pharmacovigilance. Post-marketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases. The FDA operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also conducts active surveillance of certain regulated products.

our Blog

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Advisory Panel
Prof. Timothy Andersson

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Dr. Sophie Toya   

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s,
Dr. David Schmitty
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s,
Slide
Advisory Panel
Dr. Douglas Yau, PhD 

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Dr. David Schmitty
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Prof. Timothy Andersson

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Dr. Sophie Toya   

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Dr. Douglas Yau, PhD 

Disclaimer:

The information contained in this website is for general information purposes only. The information is provided by McGenome LLC and while we try to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

However, McGenome LLC takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.

Please contact us:

For business, comments and questions:

Dr. Shahid S. Siddiqui, PhD

ceo@mcgenome.com