Drugs, Biologics and Medical Devices Development, Marketing, and Regulatory Affairs
Accelerating drug development with comprehensive market strategy and regulatory affairs expertise
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.
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
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.
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.
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.
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.
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.
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.
Useful Development for a SARS-Cov2 Nasal Vaccine
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