Consultants and affiliate consultants

has over 20-plus years of pharmaceutical experience. Brock began his career as a staff clinical hospital pharmacist, working in a progressive clinical environment in the Chicago, IL area. He served in various clinical project management and clinical consultancy roles with Astellas Pharma, Fujisawa, and Eli Lilly, among others. His expertise includes, but is not limited to
on-site CRA monitoring, project management, unblinded CRA assessing investigational project compliance, advising clients on EDC builds and the CRA interface with the EDC system and conducting GCP/Quality Assurance (QA) audits to clinical sites in the USA. Therapeutic areas include Oncology [Solid Organ and Hematologic], Cardiology (Heart Failure and A-Fib Ablation device), Dermatology (Atopic Dermatitis and Psoriasis), Infectious Disease (Pre-Natal Staph vaccine and adult genital HSV Vaccine), Rheumatology (Gout and Lupus), Metabolic (Celiac Disease), Neurology (MS), Radiologic tracers in Prostate Cancer, Transplantation (Solid Organ), Virology (Hepatitis C vaccine) and Neonatal respiratory support (drug delivered via investigational nasal cannula system).

Quality Assurance Consultant
Available for consultation: audits, remediation, QMS planning and change, in-house training and personnel systems management advisor.
EU and UK GMP GLP GCP
FDA 21 CFR Parts 11, 50, 54, 56, 210, 211, 312
ICH Q7A, E2A, E6
Education
Honors Degree in Botany with Microbiology (Reading University, 1990)
Doctorate in Biochemistry and Molecular Biology (University of Cambridge, 1995)
LRQA & IRCA Lead Auditor: Quality management systems: pharmaceutical manufacturing and packaging (ISO9001, PS9000)

Experience
Strong biotechnology background in vaccine and anti-toxin manufacture. Twenty-five years in public and private sector. cGMP Quality Manager (twelve years); novel medicines for FDA, MHRA, EU/EEA, ICH and TGA controlled markets. Successful Specials Licence acquisition for
manufacture novel recombinant DNA-based medicines and anti-toxins.
IMP and API experience
APIs: specialist in therapeutic antibodies for fractionation from hyperimmune apheresis plasma. Extensive world-wide travel for supply chain verification. Novel drug registrations in UK, USA.
Advanced therapy medicines (ATMPs): e.g. rDNA, siRNA. Projects: (1) GMP biomanufacturing recombinant vaccine vectors for anti-tumour therapy (Clinical Study Phase I, Jenner Institute), (2) Transdermal patch delivery. (3) Anti-toxins, (4) rDNA antigen vaccines.
QMS
All quality management system processes and documentation (paper/electronic/hybrid/cloud).
FDA, MHRA
Hosted MHRA and FDA inspectors. All successful first registrations (1) Safety pharmacology and toxicology, (2) cGMP manufacturing licences, (3) ongoing successful surveillance and reassessment by competent authorities.
Training provider
Trainer in how to apply quality management systems to maintain organizational success. Bespoke and standard packages provided.
Calibration and Testing – UKAS accredited test and calibration laboratories – Compliance audits.

Elizabeth is a Clinical Research professional who is a Registered Nurse with a Post Graduate qualification in Pharmaceutical Science and Drug Development located in Adelaide, Australia. She has worked in clinical research for 25+ years and has been directly involved in a multitude of therapeutic areas across Phase I to Phase IV trials. She has significant experience in the Asia Pacific region with a strong understanding of the culture, work ethic and regulations. She has held management and executive management roles in both local and international Pharmaceutical and Clinical Research Organisations.
Elizabeth has extensive experience in GCP audits, including but not limited to, Vendor audits (e.g. Information Technology Service provider, Virology Laboratory, Central Laboratories, Phase I Units, Research Ethics Committee and CRO’s), Investigator site audits, Data Base audits, Contract Compliance Audits and For-Cause Audits.

has vast experience with over 12 years in the research industry successfully completing audits, FDA inspection preparation and assistance, monitoring clinical trials, and clinical trial management. Julie is skilled in U.S. FDA, ICH E6 (R2) Good Clinical Practices (GCP) and the EMA. She works with GCP customers to execute strategic plans to identify, implement and ensure compliance with all regulatory and company SOPs. Julie has worked throughout the United States as well as Canada, Spain, Germany, Hungary and England prepping sites for FDA/EMA Inspections. She has completed hundreds of monitoring visits, audits, FDA inspection preparation visits and on-site assistance during FDA inspections. Julie is an enthusiastic, determined and a highly motivated individual who will be an asset to your team.

provides expertise in a variety of areas. She is certified as a clinical research auditor and performs research department compliance risk assessments and GCP clinical trial audits. She has more than 30 years of clinical nursing experience and acquired clinical research skills during her work with world-renown investigators at Baylor College of Medicine and Houston Methodist Research Institute. She developed proficiencies in regulatory operations and compliance, research project coordination, coverage analysis, budget development, and negotiations. She graduated from Texas Woman’s University in the Texas Medical Center in Houston, Texas. She is a member of ACRP, ANA and TNA and is certified as a clinical research coordinator with the Association of Clinical Research Professionals.

· Site audits of either the entire research department or of specific trials;
· Process assessment and risk analysis;
· Development and conduction of research team training;
· Regulatory assessment;
· Study coordination services;
· Document concordance review;
· Clinical Trials Office document development such as policies and standard operating procedures, forms, templates, manuals and job descriptions and develop staff training for same;
· Coverage analysis;
· Compliance project customized with your needs.

Rahul has over 20 plus years of pharmaceutical experience He has led IND, NDA and ANDA projects from the stages of pre-development, development, filing, FDA review and approval.
He has led clinical IT projects that included drug safety systems, statistical analysis, and portfolio management. He has a thorough understanding of different phases of clinical studies and protocols and has ensured the implementation of company-wide quality systems and policy compliance to FDA, QSR, ISO 9001/13485 and EN46001 as they related to supplier management.