Brij Patel

Senior Consultant, GxPAssure

Brij Patel, BPharm, PhD, is a highly accomplished Regulatory and Chemistry, Manufacturing and Controls (CMC) specialist with more than 12 years of consulting experience across the EU, UK, and US. His career spans extensive regulatory, technical, and strategic contributions to the development, assessment, and lifecycle management of biological, biotechnology and small‑molecule products.

Before moving into consultancy, Brij spent eight years as a CMC Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA), where he also served as an expert to the European Medicines Agency (EMA) within the Biologicals domain. His assessment portfolio covers a broad spectrum of product classes, including:

• Vaccines: pandemic and seasonal influenza (H1N1v/H5N1; trivalent and quadrivalent), polysaccharide vaccines (meningococcal, pneumococcal), paediatric vaccines, BCG, Japanese encephalitis, malaria vaccines, and oncology immunotherapeutic vaccines.
• Recombinant proteins: filgrastim, PDGF (becaplermin), somatropin, insulin, etanercept, monoclonal antibodies (e.g., trastuzumab), and recombinant clotting factors.
• Advanced Therapy Medicinal Products (ATMPs): contributing to MHRA/CHMP scientific advice procedures.
• Blood and plasma‑derived products: including C1‑esterase inhibitor, clotting factors, and immunoglobulins.
• Other biologics: such as heparin, oligodeoxynucleotides, and pancreatin.

In addition to his biologicals expertise, Brij has significant experience with small‑molecule products, including fermentation‑derived products, modified‑release formulations, multiple dosage forms (oral, transdermal, nasal, parenteral), and bioequivalence evaluations across a variety of therapeutic areas.

Brij has served as Lead EU Assessor for numerous marketing authorisation applications, abridged submissions, clinical trial applications, and post‑approval variations, bringing deep regulatory insight to global product development strategies. He has also contributed as an author to several EMA/CHMP regulatory guidelines, shaping regulatory expectations and scientific standards across the industry.

A qualified pharmacist, Brij holds a PhD with a research focus on vaccines and drug‑delivery technologies, underpinning his strong scientific foundation and practical understanding of product development from discovery through commercialisation.