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SERVICES

Helping companies by “hands-on” problem solving and decision making to successfully take products from R&D laboratories to commercial plants

Pharmaceutical Development

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  • Process development and technology transfer for solids and parenterals.

  • Holistic development support based on principles outlined in ICH Q8.

  • Phase & Risk based approach to managing development challenges 

FDA & EMA Filings

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Document preparation/reviews, audits and reviews, compliance problem resolution, training, regulatory affairs strategic assistance, preparation and review of filings..

GMP Compliance

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  • SOP management & creation for all GMP operations.

  • Developing & implementing broad range of Quality Systems

  • Developing training system and/or material; delivering training and onboarding of newer colleagues. 

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