Expertise Extended to The Following Therapeutic Areas

Center of Excellence in Life Sciences

  • Pain Management & Chiropractic Care

  • Dermatology, Skincare, and Anti-Aging Solutions

  • Pediatrics, Genetics, and Rare Disease

  • Gastroenterology

  • Endocrinology, Hormones, Metabolic Disorders, and Nutrition

  • Allergy and Clinical Immunology

  • Holistic Medicine and Weight Loss

  • Men’s and Women’s Health

  • Obstetrics & Gynecology

  • Immuno-oncology

  • Hematology

  • The Hallmarks of Cancer, Oncology Solutions, Benign and Malignant Disorders

The biopharmaceutical research and development journey is a rigorous process that spans from initial discovery to potential FDA review and approval. Less than 10% of drugs entering clinical trials successfully navigate the entire journey and receive marketing authorization. This success rate can vary due to several factors, including the complexity of the drug, its therapeutic area, the geographical region, and the specific regulatory environment of that region. Additionally, each drug must meet unique requirements to progress through the development process and eventually reach approval.

The process of developing a new pharmaceutical product involves several stages, each with its own set of requirements and regulations.
Here’s an overview of the key steps:

  1. Basic Research:
  2. Non-Clinical Research
  3. Investigational New Drug (IND) Application
  4. Clinical Trials:
  5. New Drug Application (NDA) Filing
  6. FDA Review and Potential Approval
  7. Inspections
  8. Scale-Up to Manufacturing
  9. Marketing Authorization
  10. Product Launch
  11. Post-Marketing Surveillance and Phase 4 Clinical Trials

We believe the lengthy drug approval process, which can take nearly 20 years, can be expedited while ensuring patient safety by leveraging FDA regulatory processes designed to accelerate review and approval. Moreover, the rise of novel and innovative approaches can aid in discovering new, safe solutions and potential cures for unmet medical needs. These trends reflect a shift towards a more dynamic and responsive approach in the industry, fostering rapid advancements and transformative changes in the near future.

Request For Proposal (RFP)