An independent pharmaceutical specialist.
“convert your parenteral problems into successes”
PJC Pharma Consulting
I am an independent Pharmaceutical Consultant specialising in parenteral development and troubleshooting.
After more than 26 years in the Pharmaceutical Industry/Pharmacy arena I have attained a huge wealth of insight and hands-on experience in product development and associated activities. I specialise in sterile product development plan reviews, contamination control, cleanroom and development strategy assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP worldwide, troubleshooting activities relating to parenteral products, microbial contamination and design of parenteral manufacturing facilities. Also for radiation safety and ADME study design and implementation. I have dealt with many international regulatory agencies and have written numerous regulatory submissions including INDs, NDAs, aNDAs and CTXs.
I have a proven track record for teaching, mentoring and coaching and have many years of managerial experience. I can tailor training courses to your business needs.
I can help your business.
After more than 26 years in the Pharmaceutical Industry/Pharmacy arena I have attained a huge wealth of insight and hands-on experience in product development and associated activities. I specialise in sterile product development plan reviews, contamination control, cleanroom and development strategy assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP worldwide, troubleshooting activities relating to parenteral products, microbial contamination and design of parenteral manufacturing facilities. Also for radiation safety and ADME study design and implementation. I have dealt with many international regulatory agencies and have written numerous regulatory submissions including INDs, NDAs, aNDAs and CTXs.
I have a proven track record for teaching, mentoring and coaching and have many years of managerial experience. I can tailor training courses to your business needs.
I can help your business.
Biography
Parenteral formulation development expertise and microbiology
I was the recognised expert for the development of parenteral products with GSK UK. Also, I was the named holder of the GSK manufacturing licence as the Sterile Product licence holder on the GSK Harlow manufacturing licence until early 2009.
I have substantial experience of developing many different types of parenterals including aqueous-solutions, non- aqueous solutions, lyophiles, and syringe prefills. My work has encompassed initial development activities, scale up and technical transfer into the factory network. Validation and microbial assessment of the manufacturing process, risk assessments and clinical trial designs. I have extensive experience of design and qualification of a sterile development/production unit including environmental controls and contamination controls.
I am an active member of Parenteral Drug Assoc. (USA) and the Parenteral Society (UK) and was an organising committee member for the Royal Pharmaceutical Society Arden House Parenteral Conference 2007.
I previously held the position of Honorary Lecturer of Pharmaceutical Chemistry at the University of Greenwich. Here I lectured on parenteral product development as part of the BSc (Hons) Pharmaceutical Chemistry course until the course was discontinued in c2004. Previously I was a visiting lecturer on parenteral development at the University of Kent. I lectured on microbial spoilage, contamination control and sterility as well as development of parenteral products and aseptic techniques.
Radiation expertise
I held the position of Senior Radiation Protection Supervisor (RPS) within Pharmaceutical Development, GSK (and the heritage companies SKF and SB) 1989-2009. I was responsible for and organised all ADME studies conducted worldwide and all other radiation matters within the department. I represented Pharmaceutical Development on the GSK Human Radiolabel Forum. In this role I developed targeted formulations based upon pre-clinical data to ensure correct radiation exposure whilst for clinical products I calculated radiation exposures for humans based upon clinical and safety data. I trained numerous people in ADME development and planning, formulation targeting and interpretation of clinical and non-clinical data to ensure safe and effective trials.
More.....
I was the recognised expert for the development of parenteral products with GSK UK. Also, I was the named holder of the GSK manufacturing licence as the Sterile Product licence holder on the GSK Harlow manufacturing licence until early 2009.
I have substantial experience of developing many different types of parenterals including aqueous-solutions, non- aqueous solutions, lyophiles, and syringe prefills. My work has encompassed initial development activities, scale up and technical transfer into the factory network. Validation and microbial assessment of the manufacturing process, risk assessments and clinical trial designs. I have extensive experience of design and qualification of a sterile development/production unit including environmental controls and contamination controls.
I am an active member of Parenteral Drug Assoc. (USA) and the Parenteral Society (UK) and was an organising committee member for the Royal Pharmaceutical Society Arden House Parenteral Conference 2007.
I previously held the position of Honorary Lecturer of Pharmaceutical Chemistry at the University of Greenwich. Here I lectured on parenteral product development as part of the BSc (Hons) Pharmaceutical Chemistry course until the course was discontinued in c2004. Previously I was a visiting lecturer on parenteral development at the University of Kent. I lectured on microbial spoilage, contamination control and sterility as well as development of parenteral products and aseptic techniques.
Radiation expertise
I held the position of Senior Radiation Protection Supervisor (RPS) within Pharmaceutical Development, GSK (and the heritage companies SKF and SB) 1989-2009. I was responsible for and organised all ADME studies conducted worldwide and all other radiation matters within the department. I represented Pharmaceutical Development on the GSK Human Radiolabel Forum. In this role I developed targeted formulations based upon pre-clinical data to ensure correct radiation exposure whilst for clinical products I calculated radiation exposures for humans based upon clinical and safety data. I trained numerous people in ADME development and planning, formulation targeting and interpretation of clinical and non-clinical data to ensure safe and effective trials.
More.....
Testimonials
Formulation Development Consultancy
From reviewing draft development plans, stability and development reports, through to full plan development from selection through to commercialisation and marketing. Including interactions with international regulatory agencies PJC Pharma Consulting Ltd can assist your business. Expert report writing for product assessments and submission reviews can all be offered depending upon your needs.
Please contact me to discuss your specific requirements.
Please contact me to discuss your specific requirements.
Development Planning
Let me assist in reviewing your development plans and protocols, ensure compliance with latest requirements and emerging technologies and trends. PJC Pharma can add value but ensuring coherent plans are linked to development and commercial objectives, aligned with the latest ideas. Build upon a careers worth or manufacturing and development experience to enable your products to progress to market quicker with a 'right first time' approach.
Include latest QbD ideas and meet the expectations of ICH Q8 and Q9 from plan initiation.
Include latest QbD ideas and meet the expectations of ICH Q8 and Q9 from plan initiation.
cGMP Audits
I can offer facility audits to cGMP standards based upon my detailed and hands on experience of both manufacturing and development activities for a range of dosage forms, not just parenteral.
Audits of parenteral facilities and development plans will consider current and emerging requirements such as current EU Annex 1 requirements.
Audits of parenteral facilities and development plans will consider current and emerging requirements such as current EU Annex 1 requirements.
Training
I can provide tailored training courses, either at your place of work or at a location of your choice.
Training in numerous areas, please contact me to discuss your requirements:
Examples include:
These are only a few examples to give an idea of the breadth of training that I can offer.
Training in numerous areas, please contact me to discuss your requirements:
Examples include:
- Parenteral awareness, development
- Sterile product manufacturing
- Implications for microbiology
- Audit training
- Expectations from a FDA or EMEA type audit
- Technical report writing
- Good managerial practices for scientific supervisors
These are only a few examples to give an idea of the breadth of training that I can offer.
Due Diligence Reviews
Using my years if experience in a product development role I can assist or autonomously conduct 'due diligence' activities to support your companies expanding portfolio. This can be applied to all dosage forms and all stages of development from candidate selection molecules through to compounds in Phase 3 clinical trials.
Please contact me to discuss your specific requirements.
Please contact me to discuss your specific requirements.
Parenteral Auditing
Utilising my experience in the Pharmaceutical Industry I can conduct audits of pharmaceutical development and manufacturing plants, covering cGMP, safety, cGLP.
I have personal experience of auditing laboratories and manufacturing plants in UK, USA, throughout the EU and also in Japan. As a trained auditor I can conduct pre-Regulatory agency audits, couple that with pre-audit training or FDA/EMEA audit awareness training and I can help your business avoid costly delays, oversights or mistakes.
I have personal experience of auditing laboratories and manufacturing plants in UK, USA, throughout the EU and also in Japan. As a trained auditor I can conduct pre-Regulatory agency audits, couple that with pre-audit training or FDA/EMEA audit awareness training and I can help your business avoid costly delays, oversights or mistakes.
ADME Design and Troubleshooting
With over 20 years as a Senior Radiation Protection Supervisor (SRPS) within the pharmaceutical industry, and for the most part being responsible for clinical study supply, labelling and formulation development I am well placed to critique plans for your Administration Distribution Metabolism and Excretion studies.
I can advise on troublesome formulations, especially those involving high radioactivity and low solubility.
I can critique regulatory submissions and provide expert analysis reports on study plans or stability data interpretation.
Please call me to discuss your requirements.
I can advise on troublesome formulations, especially those involving high radioactivity and low solubility.
I can critique regulatory submissions and provide expert analysis reports on study plans or stability data interpretation.
Please call me to discuss your requirements.
News
I will be attending the PDA Annual Conference in Orlando, Florida in March 2010, to meet me there please e-mail me.
Contact Details
Contact me on:
00 44 (0) 7774 841319
PJC Pharma Consulting
Registered office:
Woodridge House
Earlsbrook
Bacton
Stowmarket
Suffolk
IP4 4UA
Company No. 6902758
VAT: 981238014
00 44 (0) 7774 841319
PJC Pharma Consulting
Registered office:
Woodridge House
Earlsbrook
Bacton
Stowmarket
Suffolk
IP4 4UA
Company No. 6902758
VAT: 981238014
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