A truly unique, bench top, computer controlled press, the Gamlen Tablet Press is the definitive solution for low volume material testing and is ideal for the small scale manufacture of clinical trials materials and small volume pharmaceutical tablets under tightly controlled conditions.  It is suitable for GMP manufacturing.

The press has a wide variety of applications including:

• Production of small batches of tablets for clinical trials materials, as specials, or for sale
• Compressibility studies for product development or quality control purposes
• Micro-tablet manufacture
• Quality control

To register your place at this event, please contact: Philippa Bevan on +44 (0)1782 79 11 99 or email: marketing@pharmdservices.com

Pharmaceutical Development Services Limited (PDS) is delighted to announce a new strategic alliance with Compliance Control, and the addition of analytical and dossier rectification expert, Sean McCrossen, to their team of consultants.

Compliance Control are quality, regulatory, compliance and validation specialists with over 25 years experience in the pharmaceutical sector. With a proven track record of services and software products designed specifically to enhance quality, improve efficiency and pass regulatory inspections, ComplianceControl Centre provides visible and clearly defined Key Compliance Indicators (KCI), to help companies meet regulatory goals and standards.

The strategic alliance between PDS and Compliance Control has been brought about thanks to Graham Clapperton, Associate Director of Quality at PDS.

In addition, PDS are also extending their technical expertise to include a CMC regulatory dossier rectification expert Sean McCrossen.  A PhD chartered chemist, Sean has extensive expertise in regulatory writing, analytical techniques and chemistry and manufacturing control (CMC) management. A regular contributor to analytical trade magazines, he is a specialist in chromatographic, solid state and pharmaceutical analysis techniques and their application in pharmaceutical development and quality control. 

PDS, with their expertise on working with data dossiers, will join forces with Compliance Control to utilise the company’s online Electronic Quality and Document Management system including cGARD (current Global Automated Regulatory Database). This will enable PDS to address the compliance issues of clients that are struggling to meet the challenges of:
• increasingly complex regulatory compliance, and
• the need to bring regulatory dossiers up to current regulatory standards.

PDS Managing Director Michael Gamlen commented, “Many holders of Marketing Authorization Applications (MAA) for small products find it hard to maintain the scientific standards required to keep their products on the market.   It is a legal obligation to ensure that manufacturing standards and analytical methods for control of pharmaceutical products are continuously updated.  However, as techniques improve in both areas, MAA holders with limited resources find it difficult or impossible to know how this should be done.  We fill the gap between their understanding and the standards which need to be met.  At PDS we have the right resources to meet client needs in these areas. Sean is a highly experienced consultant whose specialist skills can assist any company to bring their CMC dossiers up to current scientific standards. We also have experts in active pharmaceutical ingredient sourcing and manufacturing. Our new alliance with Compliance Control ensures PDS is at the cutting edge of the regulatory and quality control market which is an essential requirement for all of our clients. ”

David Forrest, Chief Executive of Compliance Control Limited stated, “We are really pleased to announce this partnership with PDS.

ComplianceControl Centre is a fully compliant and validated, hosted Electronic Quality and Document Management System. The availability of this product provides functionality at an affordable price, for smaller to medium sized organisations, that larger pharmaceutical companies have had access to for years.

The partnership with PDS will allow us to ensure that any organisations, that are updating their MAA, can have access to ComplianceControl Centre to ensure that all the relevant documents and data are under control. Other typical Quality functions such as CAPA, deviations, change control, audits, training records and customer complaints, are also available.

Our link between regulations and compliance is unique and we look forward to working with PDS to provide this new functionality to the market place.”

PDS has recently been working with the UK arm of a group which manufactures and distributes herbal, anthroposophic and herbal medicines in over 51 countries worldwide. It is supporting the company in achieving the registration of their “top 24” homeopathic medicines in the UK and Ireland through the so-called Simplified Scheme for homeopathic products. 

The Simplified Scheme is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims. Nine registrations have been granted in Ireland so far and as many are pending in the UK.