Medical Writing for Biotechnology Companies

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REGULATORY SERVICES: BIOTECH INDUSTRIES

The biotechnology domain is currently witnessing significant changes through innovations, continuous research, and technological advancements. The Indian biotechnology industry is rapidly growing. The current value is estimated to be around USD 70 billion (2020) and is projected to reach USD 150 billion by 2025. The COVID-19 pandemic and the development of several vaccines thereafter had increased the importance of the biotechnology sector, not only in India but throughout the world.

Biotechnology involves understanding the diseases, and their causative pathogens that help to initiate the development of treatments for the benefit of mankind. This industry is capital intensive, and millions of dollars are at stake while developing a new drug. Further, the research required to develop successfully commercialized products is more comprehensive as compared to pharmaceutical products. It is the reason why biotechnology-related formulations are expensive. Sometimes organizations have to bear severe losses due to lengthy researches or due to failure of the product during clinical trials.

Several areas in the biotechnology domain are believed to grow at a much rapid rate than the overall industry. Some of them are:

Personalized medicines: It is one of the fastest-growing domains in the biotechnology industry. The treatment is provided to the patients based on their genetic framework.
Immuno-oncology: Despite several developments in the treatment of cancer, it is still considered an untreatable and fatal disease. Through immune-oncology, biotechnology organizations are developing advanced treatment options that would stimulate the immune system of the body and kills cancerous cells.
Chimeric antigen receptor -T cell therapy (CAR-T): It is one of the best examples of customized treatment. The T-cells of the person suffering from cancer are obtained, and a chimeric antigen receptor is added to these cells. The modified cells are infused into the patient to target the cancerous cells.
Gene Therapy: Gene therapy is another growing area that is witnessing a lot of research. It involves the use of genes to cure the disease. It may include replacing a disease-causing gene, inactivating a disease-causing gene, or introducing a new gene in the body. Several cellular and gene products have already been approved by regulatory authorities throughout the world.
Theranostics: This technology involves both the diagnosis and therapy for cancer. It involves one radioactive medicine to determine the presence of tumor while the other radioactive medicine to treat the tumor. This treatment area is related to personalized treatment.
Vaccines: The importance of vaccines is increased during COVID-19. Apart from this, vaccine pays a significant role in preventing several diseases in children and adults.
Regenerative medicines: Regenerative medicine involves the replacement or healing of tissues or organs damaged due to age, injury, trauma, or congenital conditions. Regenerative medicine includes artificial organ production, tissue reengineering, and therapeutic stem cells.
Neurological disorders treatment: Millions of people die or develop disabilities due to neurological conditions. There is an unmet need for new and effective treatment for neurological conditions. Biotechnological breakthroughs such as brain mapping may help in developing innovative and effective formulations.

REGULATORY FRAMEWORK IN BIOTECHNOLOGY

The biotechnology regulatory framework is somewhat different from the pharmaceutical regulatory procedure. Biotechnology is related to cells, tissues, and living organisms, and thus, several laws regulate biotechnology researches and commercialization. Many laws apply to the organizations dealing in biotechnology research. Further, the regulatory requirements for biotechnology formulations are stringent and require accurate and comprehensive data presentation. Omission of any data or ambiguous information in the regulatory filing documents may result in delaying or rejecting the application.

NEED FOR MEDICAL WRITING SERVICES IN BIOTECHNOLOGY DOMAIN

As there is an increased strictness and requirement of comprehensive data presentation in a clear, comprehensive, and unambiguous language, there is an increasing demand for regulatory writers for biotechnology products. The biotechnology regulatory writers understand the regulatory procedure and are extensive experience in writing applications for marketing approval.

HOW WE CAN HELP YOU?

SMIQGEN helps you in writing a technically sound and accurate regulatory document for biotechnology formulations. We can help you in preparing investigator brochures, ICH GCP compliant Clinical Study Reports, patient safety narratives, the common technical document including both the clinical and non-clinical phases, and pharmacovigilance documents that include Periodic Safety Update Reports.

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