Advertisement Pharmaceutical Consultancy PDS Expands to Include a Strategic Alliance with Compliance Control Ltd. and a Work Team to Include CMC Dossier Rectification Expert Sean McCrossen - Pharmaceutical Business review

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Pharmaceutical Development Services

Pharmaceutical, Regulatory and Medical Device Consultancy

Pharmaceutical Consultancy PDS Expands to Include a Strategic Alliance with Compliance Control Ltd. and a Work Team to Include CMC Dossier Rectification Expert Sean McCrossen

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, pass regulatory inspections, Compliance Control Centre provides visible and clearly defined key compliance indicators (KCI), to help companies meet regulatory goals and standards.   Sean

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 all the compliance issues of clients that are struggling to meet the challenges of:

  • Increasingly complex regulatory compliance
  • 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 Ltd. Stated, "We are really pleased to announce this partnership with PDS. Compliance Control 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 the smaller to medium organisations, that the 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 Compliance Control 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."