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"Providing solutions to pharmaceutical issues across the globe"
get in touch

Why Choose PJC Pharma Consulting Ltd?

PJC Pharma Consulting Ltd was created by Paul Cummings in early 2009, its aim at that time was to provide parenteral expertise to the pharmaceutical industry. With Paul's specific experience in a variety of roles within NHS Pharmacy, Smith Kline & French, SmithKline Beecham and Glaxo SmithKline he provided a key contract resource to industry partners.

Whilst initial clients concentrated on Paul's niche parenterals expertise it soon became apparent that his breadth of experience in solid oral dose forms along with Quality and Regulatory areas were also in high demand and the company expanded to offer these services.

Spreading from the UK to mainland Europe, PJC Pharma has satisfied and returning clients across the globe. With Associate Consultants Dr Simon J Holland, Beverley K Atkins and Shane P Smith, PJC Pharma now covers the areas of:

Parenteral & Liquid dose forms
Solid oral dose forms
Inhaled dose forms
Radioactive (ADME) formulations
Pharmaceutical Microbiology
Nano-particulate systems
Quality Management Systems
Quality by Design
GxP Auditing of Primary and Secondary manufacturing facilities
Due Diligence
API sourcing
Process Scale up & Trouble shooting

With all associate consultants having over 30 years Industry experience PJC Pharma's vision is a simple one, to provide a cost effective, quality service based upon practical hands on experience to Pharmaceutical Industry clients. We aim to continue to grow across the globe whilst maintaining the personal and individual approach that has been so welcomed by clients to date. Our quality mantra is simple "PJC Pharma has a fundamental commitment to Quality. Directors, staff and Associates play an active role in Quality Assurance, strive to excel and meet all of our clients specific needs. Excellence and Value in all that we do". Don't exceed your expectation, redefine them with PJC Pharma to a higher level.

Team Bio:

personel bio picPaul J Cummings

BSc(Hons), CBiol, FSB, CSci, EurProBiol, SRPharmS, FRI

Principal Consultant & Managing Director

Paul has over 30 years experience in the Pharmacy/Pharmaceutical Industry and left GlaxoSmithKline in 2009 to pursue a career as an Independent Consultant. His latter roles at GSK were “Head of Sterile Product Clinical Trial Supplies” and “Director of Product Development”, working on new chemical entities from candidate selection through to market launch and product line extensions.

He has broad international experience of product transfers, manufacturing and registrations and can provide an invaluable resource to any company. He has personal experience of transferring projects and technology in the UK, France, Germany, Italy, North America, South America, Japan and Australia, as well as numerous international collaborative projects.

Professional Qualifications
Paul is a:
Chartered Biologist and Fellow Member of the Society of Biology (CBiol, FSB)
Fellow of the Royal Institution of Great Britain (FRI)
Active member of the Parenteral Drug Association
Registered as a European Professional Biologist (EurProBiol)

Parenteral formulation development expertise and microbiology
Paul is a recognised expert for the development of parenteral products. He was the named holder of the GSK manufacturing licence for Sterile Product manufacturing in the UK until early 2009. He has substantial experience of developing many different types of parenterals including:
•aqueous-solutions
•non-aqueous solutions
•lyophiles
•syringe prefills
•ampoules
•vials
•radiolabelled products.

He has worked from the initial development activity stage, candidate selection, through scale up and technical transfer into the factory network and has expertise in validation and microbial assessment of the manufacturing process, risk assessments and clinical trial designs.

He also has extensive experience of design and qualification of a sterile development / production unit including environmental controls and contamination controls.

Radiation expertise
Paul was a Senior Radiation Protection Supervisor (RPS) for over twenty years within the pharmaceutical industry and was responsible for and organised all pharmacy aspects for all ADME studies worldwide and all other radiation matters within GSK. He developed targeted formulations based upon pre-clinical data to ensure correct radiation exposure. For clinical products he calculated radiation exposures for humans based upon clinical and safety data.
He trained numerous people in ADME development and planning, formulation targeting and interpretation of clinical and non-clinical data to ensure safe and effective trials.

Non-parenteral formulations
Paul also has significant experience of product development from candidate selection through to NDA/MAA submissions both for new chemical entities and product line extensions (PLEs) of a number of oral dosage formulations:
•tablets manufactured by direct compression, wet compression and high shear granulation
•tablets coating: enteric and aqueous
•bilayer tablets
•capsules
•oral suspensions

Regulatory expertise
Paul has hosted FDA meetings, FDA pre-Approval inspections and MHRA inspections. He has many years of experience leading trans-national teams based in Japan, EU and USA for development of products for the Japanese and Worldwide commercial markets.

Training
Paul was an Honorary Lecturer of Pharmaceutical Chemistry at the University of Greenwich where he lectured on parenteral product development as part of the BSc(Hons) Pharmaceutical Chemistry course until the course was discontinued in c2004. He has also been a visiting lecturer on parenteral development at the University of Kent. He lectured on microbial spoilage, contamination control and sterility as well as development of parenteral products and aseptic techniques.

personel bio picDr Simon J Holland

Senior Associate Consultant

Ph.D. CChem, MRSC, CSci

A consultant specialising in nanomedicine and product development troubleshooting. With recognised expertise in the field of nanotechnology, an excellent track record of technology transfer, product registration and post marketing support.

A leader of people with proven skills in product development and process troubleshooting. Excellent Team worker, communicator and innovator. With a reputation of completing tasks whatever the timeline / resource allocation. Acknowledged skill in chairing meetings.

Simon is a recognised expert in the field of nanomedicine. He designed and commissioned two large manufacturing plants and managed all the nanotechnology developments within GSK Product Development over a 17 year period. Created and led a cross Pharmaceutical Development / Factory Nano User group to share appropriate knowledge and best practice.

Since 2012 he has been the Chair of ISO TC 229 committee on Nanotechnologies, and will held this position until 2016. He has contributed to JWG1/PG12 – Technical Report group, covering the Framework for Identifying Vocabulary Development for Nanotechnology Applications in Human Healthcare

Since 2013 Simon has been a member of the UK NANoREG Steering Group which is developing a common European approach to the regulatory testing of Manufactured Nanomaterials. This requires him to work with members of the UK Government Defra department, small companies and academic bodies.

personel bio pic

Dr Karen A Cummings, BPharm

Scientific Director & Project Management

Dr Karen Cummings, an industrial pharmacist and project manager, provides project management services to clients of PJC Pharma Consulting Ltd.

Karen spent many years at SmithKline Beecham then GlaxoSmithKline working in Pharmaceutical Development in a number of technical positions, at that time as well as developing new products and line extensions she continued to develop her former Doctoral work on compaction simulation. Her move into R&D project management was a culmination of many years of practical and managerial experience and Karen honed her skills across a spectrum of R&D departments.

personel bio pic
Beverley K Atkins

Associate Pharmaceutical Consultant

BSc (Hons), MRSB, ARQA, SRPharmS

Beverley has a diverse range of experience across the pharmaceutical and education industries.  Decades spent at GSK, SK&F, Intertek and other institution’s has given Beverley an invaluable perspective of regulatory compliance and requirements.

A pharmaceutical scientist and quality professional that conducts all work to regulated standards, including study plans, interim and final project reports, compliance checks and supply chain assessments. An excellent communicator and an accomplished Study Director. Beverley has worked and trained to meet the GLP and GMP standards expected of all Pharmaceutical and Analytical Laboratories for decades. A very pro-active well-organsied worker who has a track record in designing work/studies and carrying to completion. All works completed were peer reviewed and have been audited by agencies such as the Medicines and Healthcare Products Regulatory.

personel bio picShane P Smith

Associate Pharmaceutical Consultant

BSc (Hons), CChem, MRSC

Shane honed his expertise in analytical chemistry over many years at GSK, Shell, Anachem and other industrial positions.  His expertise in extractables and leachables testing has been invaluable for many drug filings (NDA and BLAs), thus demonstrating an expertise in this field.

A specialist in trace analytical chromatographic techniques, with extensive knowledge of method development & validation requirements. Excellent communication skills developed during time spent in commercial environments and from 5 years running chromatography training courses.

personel bio pic

Laura D Cummings

Administrator and IT

Laura is a science undergraduate currently studying for her honours degree, she looks after the team's administration issues, website, work planning, travel and office activities.

 

 

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