What does life sciences mean?
Life science is a very large field of study that examines every living thing on earth. From bacteria to begonias to beluga whales, life sciences aim to learn everything about living organisms on this planet.
Life science includes the in-depth study of plants, animals, viruses and bacteria, single-celled organisms, and even cells. Life sciences are the study of how these organisms live, ascertain their characteristics features, and also determines their period of survival.
The various branches that fall under life sciences are:-
- Cell Biology
- Marine biology
Which does Authority deal with life sciences in India or which Authority is responsible for Life science Regulation?
There is multiple/ample numbers of Authorities in India that regulate Life sciences in India amongst which one of the most important is the Ministry of Science & Technology.
Our Firm represents a number of biotech and pharmaceutical companies, medical device manufacturers, and clinical research organizations with the competence to advise on sector specific critical legal issues including:
- Permissibility of ingredients and product formulations under food and drug laws.
- Legal and regulatory issues relating to clinical trials, informed consent of the clients and other documentation, presentations before the ethics committees, reporting of completion of studies, and adverse drug reactions.
- Financial and technology collaboration between entities within the sector, financing, and acquisitions with tax-efficient structures.
- Drafting and negotiation of agreements governing the distribution, outsourcing, franchising, marketing, licensing, and consulting of pharmaceuticals and medical devices, and establishment of research and development facilities in India.
- Compliance with data protection and privacy covenants and conditions and confidentiality of results as well as records.
- Avoidance and resolution of product liability disputes by the process of litigation and mediation.
- Proposed regulatory and legislative changes, by submitting suggestions and opinions with the expert committees and the Government.
- All the Aspects of professional ethics guidelines, governing the conduct of physicians in the recruitment of subjects for clinical trials and in the dissemination of information about new drugs and medical devices in the market.
- All stages of regulatory compliances and defense of enforcement actions and investigations conducted against it.
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