B: Alan Banyard

PhD

ABPharm

Alan Banyard founded ABPharm consultancy in 2007.  Alan is qualified to PhD in analytical chemistry with over thirty years experience in Pharmaceutical Analysis, CMC and Drug Development to senior management level. 

ABPharm offers a flexible and efficient service, specialising in CMC, particularly Analytical Development, Quality and preparing for Regulatory Submissions. 

Alan's expertise includes, analytical methodology, validation, drug characterisation, release testing and stability testing.  He has a broad experience of development of API and a comprehensive variety of formulations and devices including inhalation.  Alan can assist you in all CMC related activities.  The objective is to be able to support you throughout the development of your product.

Alan can advise on Quality aspects, specifications, SOPs and Regulatory Guidelines.  This includes review, or preparation of sections of your regulatory submission packages or help to identify potential issues and questions that might concern the regulators.

Alan has extensive experience with many analytical CROs and specialise in contracting out.

Previously, Alan held the following posts.

Management

Vectura Group plc (Inhalation, Pharmaceutical).   Analytical Development Manager: Responsible for analytical group and physical characterization service.  Responsibility for outsourced analytical studies including bioanalytical.

Provensis Limited (Device development).  Analytical Development Manager: Virtual company, development of a novel non-surgical treatment for varicose veins (Varisolve®).   Joined Provensis in its start-up phase, recruited team and contract facilities and built up successful analytical program from scratch. Planning and execution of stability, compatibility and investigational studies for API and a drug/device combination product.

British Biotech Pharmaceuticals  Manager, Analytical Development:  Head of Department responsible for developing and applying analytical methods to NCEs, intermediates and raw materials in support of clinical and preclinical development.  Projects included preformulation studies, and investigations of polymorphs, solvates and their crystal habits.

Hafslund Nycomed (Pharmaceuticals, Linz, Austria) Analytical Chemistry Manager: Managed analytical department supporting Chemistry Clinical development and research projects.  Attained good conversational standard of German.

Laboratory

Analyst/Senior Analyst with Zeneca Pharmaceuticals, Parke Davis, Optrex, William Warner Limited

Country experience

UK

Austria

Germany

USA

Professional affiliation

Member of the Royal Society of Chemistry (CChem MRSC)

Expertise area

Analytical method development and validation

Analytical characterisation

Biotechnology

API manufacture

Chemistry, manufacturing and controls

Clinical trial applications (EU, USA, Canada)

CMC

Drug development

FDA NDAs

GMP auditing

Good Manufacturing Practice (GMP)

Investigational Medicinal Product Dossiers (IMPDs)

Pharmaceuticals

Phase I studies

Phase II studies

Phase III studies

Phases I-IV

Preparation of Quality Modules

Product development

Quality assurance

Quality control and management

Quality modules of CTD - 2.3 and 3

Quality Systems

Company (as employee)

Vectura

Contact Details

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