Compliance & Quality

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    Harlow, UK, 5th May 2017On 2nd May 2017 the EMA and ...

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    The European Medicines Agency (EMA) will launch a pilot project in February 2017 to tes...

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    Please call us on 0044 (0) 1279 441 616 or Dr David Crome directly on 0044 7769 272614 to discuss any Compliance, Quality or Qualified Person services requirements.

    Dr. David Crome
    Managing Director

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    David originally graduated in Biochemistry and has spent over 35 years working within the pharmaceutical industry, with both branded and generic multi-nationals, including Smith & Nephew Pharmaceuticals, Chauvin Pharmaceuticals, Bausch & Lomb, Ranier Technology, Tillomed Laboratories, Bristol Laboratories, Niche Generics [Unichem Laboratories, India], and latterly as European Director of Quality Assurance with Glenmark Pharmaceuticals Limited.

    David has worked within most functions within the industry covering the whole product lifecycle. There are still products being dispensed to patients which David has personally formulated, registered, process technical transferred, QP batch released, commissioned overseas distribution hubs and NHS tendered.

    David’s area of expertise is compliance and quality of the product lifecycle from product concept, through research and development, raw material and API sourcing and validation, registration, commericalisation, manufacturing, supply chain logistics, EU importation testing, Qualified Person batch release, storage and distribution, to end user complaint investigation, CAPA implementation and sometimes unfortunately batch recall from the market place.

    David is registered as a Qualified Person with the Royal Society of Chemistry since 1984 under the permanent provisions of directive 2001/83EC [MHRA Ref: 120816] with up to date Continual Professional Development filed.

    David has experience of over 50 regulatory inspections undertaken by various agencies including the MHRA, IMB, EMA, SUKL Czech Republic, USFDA, MCC South Africa and Anvisa Brazil, in England, Ireland, Czech Republic, Argentina and India.

    David has undertaken over 150 audits covering the whole product life cycle including R&D, laboratories, excipients, API’s, primary and secondary packaging, sterilisers, supply chains, distribution hubs, warehouses and Finished Dosage Form manufacturers throughout the world.

    A firm believer in lifelong learning and Charles Darwin’s philosophy that “It is not the strongest of the species that survive, nor the most intelligent, it is the one most adaptable to change” although Albert Einstein’s “Things should be made as simple as possible, but not simpler” is also relevant to the compliance within the pharmaceutical industry.

    Dr. David Crome<br/>Managing Director
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