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
Quality Management Systems
Quality by Design
GxP Auditing of Primary and Secondary manufacturing facilities
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.
Paul 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.
Parenteral formulation development expertise and microbiology
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.
Dr 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.
Dr Karen A Cummings, BPharm
Scientific Director & Project Management
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.
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.
Shane 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.