Paul Gerald O'Neill

BPharm MA MRPharmS MCMI MTOPRA

Independent Pharmaceutical Consultant specialising in Quality and CMC

Contact Paul O'Neill: poneill-at-pgo.uk.com

Expertise in development of chemotherapeutic, biotechnology and biological dossiers, oral, parenteral and topical human and veterinary medicines, licence renewals and variations for various dosage forms, including vaccines.

Clients:
Ranging from large multinationals to start ups; European, American and Japanese biopharmaceutical (biotechnology and biological) and small molecule pharmaceutical manufacturers.

Flexible working options:
Experience of operating in clients' offices, research and development facilities, manufacturing sites, plus those of subcontractors, throughout Europe.
Assignments fully or partly worked from base office.

Durations:
Reflecting the individual project requirements, lasting from a few days, through time limited periods, up to several years.
Levels of activity vary from full time to occasional contact.

Areas of activity:

• Constructing Quality/ CMC Dossiers
• Preparing, Writing and Managing the CMC/ Quality Modules for CTDs (Modules 2.3 & 3)
• Production of Chemistry and Pharmacy Dossiers
• Mutual Recognition (MRPs)
• National Applications
• European DMFs (ASDMFs)
• Certificates of Suitability (CEPs) dossiers
• Variations to licences and renewals
• Quality Overall Summaries for CTDs, Module 2.3, and Expert Reviews/ Reports, Module 1.4.1

Experience in human and veterinary medicinal products:

• Vaccines
• Biologicals
• Biotechnology
• Small Molecules
• New dosage forms
• New chemical entities

PGO Consultancy Services specialises in:

Compilation of information from raw data sources

Specification and monitoring of studies to generate appropriate data

Working with clients in the development of strategies for the accumulation of information and understanding as projects progress from clinical trials through to Marketing Authorisation Application, and in response to future requirements

Ensuring the generation of a cohesive approach to the project outcomes, across non-clinical, clinical and quality documentation

Quality/ Chemistry, Manufacturing and Control (CMC) documentation reviews

Responses to Regulatory Agencies' comments

Design and management of studies for Quality/ CMC sections of CTA and MA applications

Compliance and documentation, QC and QA, reviewed and strategies prepared

To discuss your project, email Paul O'Neill: poneill-at-pgo.uk.com