Formulation and Development CRO in Mumbai is a research and development organization that focuses on the development of pharmaceutical, biotechnology, and medical device products. From preclinical testing to clinical trials and regulatory filing, the company offers services at all stages of product development.
Formulation and Development CRO has extensive experience in the development of innovative drug delivery systems, formulation optimization, and analytical method development and validation. In addition, the company provides formulation and analytic services to aid in the development of biologics, cell and gene therapies, and other novel drug delivery technologies.
Formulation and Development CRO provides services to support the development of a range of therapeutic products, including small molecules, biologics, vaccines, and gene Therapy. The company's experienced scientists can design, develop, and validate drug product manufacturing processes, as well as develop analytical methods for process controls and quality assurance.
Formulation and Development CRO also offers services for the development of regulatory strategies and submissions, with expertise in the preparation of CMC regulatory documents, including IND, NDA, and BLA submissions.
From research to final drug approval, bringing a drug product to market can take years. The average cost of developing one new medicine is $2.6 billion, including failure costs. Given that only 12% of new drug candidates in clinical trials are ultimately approved by the US Food and Drug Administration, the risk is high (FDA). 3 Pharmaceutical firms rely on contract research organisations to:
Reduce Expenditures: Outsourcing is primarily a risk-mitigation strategy.
Handle Increasingly Complex Drugs and Clinical Trials: Cell and gene therapies, antibody drug conjugates, cytotoxic compounds, and in vitro and in vivo processing methods have all made drug development more difficult.
Reduce Time to Market: CROs already have the skills and infrastructure in place to provide critical services more efficiently. They can alter drug candidates in real time based on data gathered during clinical trials.
AnaZeal Analyticals & Research Pvt. Ltd. is one of the top class Formulation and Development CRO Service provide in India, Mumbai. contact us for more details.