Clinical and Regulatory Solutions
Expert Medico-Legal consultants
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.
Our Vision
we are deeply committed to contributing to this vision. Our focus on research and development ensures that we bring forth drugs that not only address existing health challenges but also anticipate future needs. By investing in cutting-edge technologies and fostering collaborations with renowned research institutions, we aim to accelerate the discovery processes and advance our understanding of complex diseases.
In an era marked by rapid changes and increasing health demands, our vision extends beyond mere profit-making. We envision a pharmaceutical landscape that prioritizes patient safety, accessibility, and transparency. By engaging with diverse stakeholders, including patients, healthcare professionals, and regulatory bodies, we strive to create a holistic approach to pharmaceutical development that truly reflects the needs of society.
Our Mission
our mission is to pioneer innovative solutions that enhance patient care and improve health outcomes. We are dedicated to advancing the pharmaceutical industry by developing safe and effective medications that address the needs of patients around the world.
We strive to uphold the highest standards of quality and integrity in our research and development processes. Our commitment to scientific excellence drives us to explore new frontiers in medicine, ensuring that our products meet the evolving demands of healthcare.
Collaboration is at the heart of our mission. By partnering with healthcare professionals, researchers, and regulatory bodies, we aim to create a future where access to essential medicines is a reality for all. Together, we can transform lives through the power of pharmaceuticals.
Core Values
In the pharmaceutical industry, core values play a crucial role in guiding organizations toward their mission and ensuring ethical practices. Here are some fundamental core values that are essential in this sector:
1. **Integrity**: Upholding the highest standards of honesty and transparency in all dealings with stakeholders, including patients, healthcare providers, and regulatory bodies.
2. **Commitment to Quality**: Ensuring that all products and services meet stringent quality standards. This includes rigorous testing and compliance with regulations to guarantee the safety and efficacy of medications.
3. **Innovation**: Fostering a culture of creativity and continuous improvement to develop new therapies and technologies that can enhance patient care and treatment outcomes.
4. **Patient-Centricity**: Prioritizing the needs and well-being of patients in every decision made. This involves not only providing accessible medication but also engaging with patients to understand their experiences.
5. **Collaboration**: Building strong partnerships with healthcare professionals, researchers, and other stakeholders to drive advancements in healthcare and improve patient access to treatments.
7. **Compliance and Ethics**: Maintaining a strong commitment to ethical practices and compliance with all laws and regulations governing the pharmaceutical industry.