SanKav Pharmaceuticals was founded and is led by Dr. Sanjeev K. Gupta, a strategic partner, consultant and expert advisor for key clients in the pharmaceuticals industry with more than 32 years of industry experience. He has the ability to lead scientists and project teams including regulatory, compliance, quality, clinical and business departments.
We are a diverse team of highly trained professionals, from scientists and operators to engineers and quality managers. Together, we have over 100 years of combined pharmaceutical industry experience and resources:
State of the art and modern facilities with automated and advanced technologies
Expert in regulatory documentation
Manage electronic data systems
Focused and timely project management
Experienced in serving virtual company & company with facilities
Flexible to meet your needs
Continuous quality improvement is our mantra
Read More About Pharmaceutical Definitions
Nutraceutical products are derived from food sources. They are medical food products formulated to be consumed or administered internally. Nutraceuticals include non-specific biological therapies used to promote general well-being, control symptoms and prevent malignant processes. Its plays an important role in a plethora of biological processes, including antioxidant defenses, cell proliferation, gene expression, and safeguarding of mitochondrial integrity. Nutraceuticals have attracted considerable interest due to their potential nutritional, safety and therapeutic effects
Categories: dietary supplements, functional food, medicinal food, farmaceuticals
Definition of Biologics:
Biologics can be derived from animal and plant sources. “Biology is a branch of science that deals with living organisms and their vital processes. Biology encompasses diverse fields, including botany, conservation, ecology, evolution, genetics, marine biology, medicine, microbiology, molecular biology, physiology, and zoology.”
Pharmaceutical is Synthetic Drug: small molecules, peptides, other complex drugs, etc. (File to FDA as NDA - New Drug Application)
Biological is Natural Drug: Antibodies, Cells, Genes, Proteins, Polysaccharides, Fatty acids, Amino Acids, Peptides, etc and combinations thereof. Also may be combined with small molecule drug conjugates example, ADC (antibody drug conjugate). (File to FDA as BLA - Biologics License Application)
Regulatory Definitions:
Over-The-Counter (OTC): FDA approved monographs of Non-prescription drugs
Brand Drugs: Pre-clinical, Pre-Investigational New Drug Application, Pre-IND, Investigational New Drug Application, IND and New Drug Application, NDA [505(b)(1) or NDA 505(b)(2)]
Generic Drugs: Abbreviated New Drug Application, a 505(b)(j) under FDA Guidances
Biologic Drugs: Biologics License Application, BLA 351(a)
Biosimilar Drugs: Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. Filed as a Therapeutic Biologics Application, 351(k); Analytical, animal and clinical studies to prove similarity to an approved biologic product.
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