Clinical and Regulatory Solutions
Expert Medico-Legal consultants
Revive Pharmaceutical Industry Services
Being a crucial segment of the Life Sciences industry, Pharmaceuticals are rapidly growing with innovation and development of lifesaving drugs. The Pharmaceutical Regulatory Affairs is the primary communication between the companies and the global Health Agencies such as FDA, Health Canada, MHRA, etc.
Ageing population, increasing income, changing lifestyle, and an increasing number of chronic diseases are the few key factors leading to the growth of the pharmaceutical industry. These factors, combined, call for improved medication, which in turn would lead to drug innovation.
Innovation in the context of a medicinal product involves multiple critical phases. Right from identifying a lead compound (in the process of drug discovery) to ensure that the drug product is safe and effective for the end user; the process involve:
Discovery and Development
Research and testing of molecular compounds and new technologies followed by the development of a new drug in the laboratory.
Pre-clinical Phase
Pre-clinical research is mainly conducted on microorganisms and animals for answering basic questions about drug safety.
Clinical Research
Drug testing on people, which is further divided into Phase I, II, III & IV of clinical trials.
Health Authority (HA) Review
HA review team thoroughly examines the data submitted by manufacturers’ Pharma CMC department for drug registration and decides whether to approve or reject the end product.
Drug Classification
Innovator/Brand-name Drugs and Generic Drugs
While an innovator drug, one that has a trading name, is protected by a patent and can be produced and sold by the company holding the patent, a generic drug is an equivalent to an innovator in terms of dosage, strength, route of administration, quality, performance and intended use and costs almost 30-80% lesser. The Pharmaceutical Regulatory affairs/ Pharma CMC wing of the manufacturer has to submit documentation attesting this equivalence in safety and efficacy to the HA for approval. When the patent protection for an innovator drug expires, generic versions of the drug can be offered for sale in consent with concerned HAs.
Prescription Drugs and Over-The-Counter (OTC) Drugs
While a prescription drug can be availed only when a pharmacist dispenses it on the order of a physician or physician assistant or qualified nurse, an OTC can be ordered and consumed by consumers themselves.