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ICH Guidelines for Pharmaceuticals

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedSeptember 29, 20230Comments

Drug Development is a long and costly process consisting of several steps. Generally, it takes 12-15 years for new drug development to reach the marketplace. This process further gets prolonged when one wishes to introduce this new drug to various world markets. As every country has its national regulations and certain requirements, the company that…

Reducing Pharmacy Waste: Proper Medication Storage

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedSeptember 23, 20230Comments

The statement "Reducing Pharmacy Waste: Proper Medication Storage" describes a series of methods and techniques used in pharmacies to reduce drug waste through appropriate storage practices. The objective is to minimize the environmental impact associated with the disposal of unused or expired medications while ensuring that pharmaceutical products are safe, effective, and viable for as…

Good Manufacturing Practices (GMP) in pharmaceutical industry: An overview

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedSeptember 22, 20230Comments

The term "quality assurance" (QA) refers to a wide notion that encompasses all of the critical steps in the production of pharmaceuticals. Quality Assurance ensures that the systems and processes used in production of a healthcare product guarantees <<product quality>>. It is a system for monitoring product quality and process performance that aids businesses in…

European Medicine Agency and Drug Approvals Process

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedSeptember 20, 20230Comments

The European Union has established a centralised regulatory authority responsible for authorising new medicines within Europe for human and veterinary use. The European Medicines Agency (EMA) is the main authority that apart from new drug approvals coordinates with the regulatory authorities of the other member state countries of the EU as well as acts as…

Clinical trial supply chain: how to optimize the process?

UncategorizedSeptember 18, 20230Comments

Conducting clinical trials is a multifaceted activity involving several stakeholders and participants. Once the trial is finalized, the entire process of supply chain for various clinical trial supplies gets activated. The entire process of sourcing, producing, packaging, distributing, and managing clinical trial supplies requires meticulous planning and is referred to as "streamlining the clinical trial…

Drug Development and Expanded Access Programme (EAP)

UncategorizedSeptember 15, 20230Comments

The development of drugs is a long process and it takes 12-15 years to complete the development for regulatory submission. Thereafter, the regulatory approval, licensing, price negotiations etc. take another 2-3 years. Thus, the availability of medicines in the marketplace and its access to the patients is a long wait. For certain health conditions and/…

Drug Approval Process - Synthetic and Biological Medicine for human use

USA Drug Approval Process : Synthetic and Biological Medicines for Human Use

Comparator Drugs, Direct to Patient Services, Enteral Feeding Tubes, Generic drugs, IPR, Named Patient Program, Nasogastric Tube Feeding, pharmaceutical cold chain products, pharmaceutical companies, Reference Listed Drugs, UncategorizedSeptember 6, 20230Comments

The centre for drug evaluation and research (CDER) is responsible for ensuring availability of safe and effective medicines in the country. CDER is thus entrusted with the responsibility of the public health. CDER is an important office under the United States Food and Drug Administration. The USA drug approval process for pharmaceutical products includes a series…

Third party pharma manufacturing: Brief overview

UncategorizedSeptember 5, 20230Comments

The manufacturing of pharmaceutical products by a third party is referred to as third-party pharmaceutical manufacturing, often known as contract manufacturing. A pharmaceutical company enters into a contract with a specialised manufacturing facility to manufacture pharmaceuticals, medical devices, or other pharmaceutical items on their behalf. This production plan is available for large scale industrial batch…

The Process of New Drug Development: Brief overview

UncategorizedSeptember 1, 20230Comments

The advancement in medical sciences has helped to understand the etiology of several known diseases as well as understanding of physiological and metabolic changes during a disease to develop new targets for the treatment. Thus there is a continuous need for new medicines development for human use. The continuous medical research and available information helps…

Exploring the Impact of Generic Drugs on Affordability

Generic drugsAugust 27, 20230Comments

Generic drugs are copies of the original branded drugs that are made available in the market once the validity of the patent protection of the branded drugs has expired. Generic drugs are identical to the original branded product as in contains the same active drug component, similar dosage form, potency, mode of administration, and intended…

Temperature Controlled Cold Chain pharmaceutical products for Logistics Operations

UncategorizedAugust 26, 20230Comments

Certain pharmaceutical products require specific temperature control for storage and transportation and to be maintained until administered to the patients. They are classified as cool chain and requires temperature control between 2-8 deg Celsius) and cold chain pharmaceutical products requiring temperatures below 0 degrees. These products are temperature sensitive and need strictest controls to maintain…

Pharmaceutical Companies based on research

Pharmaceutical Companies: Conglomeration of the various categories

UncategorizedAugust 19, 20230Comments

The healthcare industry is one of the fastest growing industries in the world with a valuation of approximately 11 trillion US dollars. Pharmaceutical Industry is an important integral part of the healthcare industry with an estiPharmaceutical mated global market of approximately 1.48 trillion US dollars as per 2022. The United States, EU, Japan, China, Brazil…