Pharmaceutical Regulatory Affairs and Compliance

Pharmaceutical Regulatory Affairs and Compliance is a critical discipline that ensures the safety, quality, efficacy, and regulatory approval of pharmaceutical products throughout their lifecycle. It encompasses the interpretation and implementation of national and international regulations governing drug discovery, development, manufacturing, clinical research, marketing authorization, post-marketing surveillance, and pharmacovigilance.

The Journal of Pharmaceutical and Pharmacology Research (JPPR) welcomes high-quality manuscripts focusing on regulatory science, pharmaceutical compliance, quality management systems, and evolving regulatory frameworks. The journal encourages research that addresses regulatory challenges, innovative compliance strategies, harmonization of global regulations, and the application of emerging technologies to improve regulatory efficiency and patient safety.

As the pharmaceutical industry continues to evolve with advances in biotechnology, personalized medicine, artificial intelligence, digital health, and advanced therapeutics, regulatory affairs professionals play a vital role in ensuring that innovative medicines meet stringent quality and safety standards while complying with global regulatory requirements.

Topics Covered

The journal welcomes submissions in, but is not limited to, the following areas:

  • Pharmaceutical Regulatory Affairs

  • Regulatory Science

  • Pharmaceutical Compliance

  • Drug Registration and Marketing Authorization

  • Regulatory Strategy and Lifecycle Management

  • Good Manufacturing Practices (GMP)

  • Good Laboratory Practices (GLP)

  • Good Clinical Practices (GCP)

  • Good Pharmacovigilance Practices (GVP)

  • Pharmaceutical Quality Assurance

  • Pharmaceutical Quality Management Systems

  • Quality by Design (QbD)

  • Pharmaceutical Validation

  • Regulatory Documentation and eCTD Submissions

  • Chemistry, Manufacturing, and Controls (CMC)

  • Pharmacovigilance and Drug Safety

  • Risk Management Plans (RMP)

  • Clinical Trial Regulations

  • Medical Device and Combination Product Regulations

  • Biosimilars and Biologics Regulations

  • Advanced Therapy Medicinal Products (ATMPs)

  • Artificial Intelligence in Regulatory Science

  • Digital Regulatory Technologies

  • Global Regulatory Harmonization

  • ICH Guidelines and International Regulatory Standards

  • FDA, EMA, MHRA, CDSCO, and WHO Regulatory Frameworks

  • Pharmaceutical Audits and Inspections

  • Data Integrity and Regulatory Compliance

  • Regulatory Intelligence

  • Regulatory Affairs for Personalized Medicine

Types of Manuscripts Accepted

JPPR invites the submission of:

  • Original Research Articles

  • Review Articles

  • Systematic Reviews

  • Meta-Analyses

  • Short Communications

  • Regulatory Science Studies

  • Clinical Research Articles

  • Methodological Papers

  • Perspectives and Commentaries

Researchers, regulatory affairs professionals, pharmaceutical scientists, quality assurance specialists, clinical researchers, industry experts, and policymakers are encouraged to submit innovative research that advances pharmaceutical regulatory science, strengthens global compliance practices, and supports the development of safe, effective, and high-quality medicines for patients worldwide.

Manuscript Submission
Kindly visit the Instructions for Authors page for detailed article preparation guidelines, information on the process of publication, article processing charges (APC), patient consent, confidentiality, and more.

Authors are requested to submit their manuscript by using Online Manuscript Submission Portal: https://www.pharmaresearchhub.com/submit.html (or) also invited to submit through the Journal E-mail Id: editor@pharmaresearchhub.com.