What we do
We help in pharmaceutical Project Management with expertise in development and manufacturing of drug substances and product from early clinical studies to commercial supply.
AMPharma Solutions can manage early stage clinical trials with working knowledge of Oncology, Cardiovascular, Respiratory and Inflammation.
Strong leadership with the ability to provide clear vision to team members, motivating and empowering them to accomplish objectives.
Our clients really value our knowledge of drug development and the ability to manage CMC aspects.
What AMPharma Solutions Offer
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Deliver Drug Substance
Manage CRO to deliver cGMP API for clinical studies. Manage quality, cost and time from early clinical to commercial manufacture.
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Deliver Drug Product
Manage CRO and deliver drug product for clinical studies to commercial manufacture. Experience in solid dosage forms, parental, extended release and inhalation.
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Manage Supply Chain
Manage supply chain of the drug substance and drug product for safety, early clinical studies and all the way through to commercial supply.
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Regulatory Interactions
Write and review Regulatory documentation for clinical studies. Participate in Regulatory interactions with Health Authorities.
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Manage Early Phase Clinical Studies
Manage CRO on behalf of the customer to deliver early phase clinical studies.
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Mentoring and Coaching
Reinforcing the important role that leadership plays in drug development, with mentoring and coaching for managers and senior leaders.
