THE NEED…

The pharmaceutical industry in developing nations has already recognized the impending threat of reduction in global market share due to challenges thrown up by the WTO product patent regime, and the need to enhance its global reach by penetrating developed markets such as North America and Europe. Faced with mounting national, as well as international regulatory and market pressures, setting up of state-of-the-art manufacturing, testing, and development facilities, and modernizing of existing facilities to meet stringent international regulatory compliance standards has become imperative for the industry.

On the other hand, the dramatic growth of generic drugs in the so called “regulated markets”, and indeed, all over the world, has opened up new opportunities to industry players. Companies in North America and Europe have begun to conduct a significant portion of their manufacturing, testing and R&D activities in the developing nations, either by way of outsourcing, or partnering with local firms who have the infrastructure and capability of meeting stringent regulatory requirements. Industry players who look to the future, and invest in creating such facilities are sure to achieve long-term profits through contract manufacturing  / testing /  research arrangements or joint ventures.


.…AND OUR RESPONSE

PharmAlliance has taken the initiative to meet this need of the industry by providing integrated project consulting services, both for setting up of new, state-of-the-art manufacturing, testing, and research & development (R&D) facilities as well as modernization of existing facilities, conforming to the most rigid international regulatory norms

We offer highly specialized conceptualization and design skills combined with a thorough knowledge of the international regulatory and business environment.

You can rely on us for complete and comprehensive expertise (including project/engineering consulting services) for conceptualizing and designing of cGXP (GMP, GLP, GCP) compliant manufacturing, testing, or research facilities (new or upgrading) and developing in-house quality systems to achieve cGXP approvals / certifications from agencies such as the FDA (USA), EDQM, EU national authorities, TPD (Canada), TGA (Australia), MCC (South Africa) the WHO, etc.

PharmAlliance’s project consulting expertise has a completely new dimension, to provide the most integrated and efficient package of services to the pharmaceutical industry.


INTEGRATED PROJECT SERVICES OFFERED FOR :

		Active Pharmaceutical Ingredients (APIs) (Non-sterile, Sterile)
		API Intermediates
		Pharmaceuticals and Biopharmaceuticals (Non-sterile, Sterile)
		• Orals : Tablets, Capsules, Liquid Orals, etc.   • Parenterals : Large Volume and Small Volume,   • Topicals : Liquids, Creams, Ointments, etc.
		Excipients  (Non-sterile, Sterile)
		Medical Devices and Disposables  (Non-sterile, Sterile)
		Testing and Research Facilities
		• Product Development Faciities   • Analytical Facilities   • Preclinical and Clinical Research Facilities
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