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Who We Are and What We Do
Achlis Laboratories is a healthcare product and service provider, based in New Jersey (USA), specializing in OTC and generic drugs distribution, supply chain management, quality assurance, and regulatory affairs. We assist our clients in sourcing high quality healthcare products at competitive prices, aided by our services in quality assurance and supply chain management for risk mitigation and process improvement in the critical phase of commercialization. Our local staff members act as your in-country "go-to" guys to execute your commercialization plan, or as "boots on the ground" to assist you in managing logistics or compliance issues and questions. We also help clients in managing critical supplier for compliance and quality improvements, lean sigma implementation, cost reduction, all aiming to remain market competitiveness. We have trained black-belt engineers, using DMAIC process and other business improvement tools, to ultimately achieve the desired results, translating into one or both of the two outcomes, speed to market (effectiveness and efficiency), robust business process (fewer compliance deviations), and ultimately dollar saving. Our business knowhow involves a blend of legal, scientific expertise, and cultural sensitivity, which allows us to complement the skillset our clients may not yet have. Our business model can be described in the following:
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- Due Diligence: Execute compliance audit against specific regulations or standards in the targeted areas.
- Compliance Guidance: Provide guidance including evaluation of written SOP's, quality controls systems and corporate oversight programs.
- Regulatory Filing: Prepare dossiers and data necessary for regulatory filing per US FDA designated format and procedures.
- Supply Chain Oversight: Provide track and trace using portable technology to ensure supply chain integrity to avoid potential cross contamination, product mixed-ups, or economically motivated adulterations, etc.
- Man-In-Plant: Provide on-site support and supervision for validation campaign or batch manufacturing to assure compliance and delivery. Assist with issue resolution of quality events which require timely on-site visits and other ground support unattainable to our clients.
- Product Supplies: Provide selected high quality products at competitive prices, supported by supply chain management and market vigilance to avoid potential supply interruption.
- Continuous Improvement: Define appropriate projects which have cost reduction potentials based on clients' needs and benefits. Determine improvements that need to be made and optimize the process including implementation and change management.
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