SERVICES


CONSULTATION NEW & UPGRADED PROJECTS SUPPORT

Bridging expertise to guide your projects Whether you need to update your Quality organization, reorganize your teams, build a new plant, prepare inspections or develop a specific project related to Quality, we have the key expertise to make it a successful achievement. Listening to stakeholder concerns and feedback is a valuable source of information that we use to improve project design and outcomes. • Undertake Feasibility studies to ensure cost effective manufacture. • Implementation of cost-effective, compliant quality management systems • Advice on legal and regulatory issues • Assistance with responses to regulatory inspection reports

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TRAINING & EDUCATION

Full range of ready made or tailored programs ranging from preliminary GMP courses to highly specialized industry hot topics.

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AUDITING AND SUPPLIER EVALUATION

Our experts have over 20 years of experience in Quality auditing and can perform a gap analysis of your organisation with respect to the current standards. This leads to regular action plans for improvement which Pharma arena can manage depending on your objectives. Our quality audits can help you in a crunch, or free up your valuable resources to focus on strategic core functionalities. - Looking for a new reliable supplier of API, Starting or Raw Material? - Looking for a partner to develop your business? - Need a routine audit to fulfill your vendor management plan? - Need to outsource auditing according to your process? Regular? On demand?

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QUALITY VALIDATION & QUALIFICATION

Top Quality. Cost-effective. Result oriented Pharma arena offers result oriented validation and regulatory affairs solutions for companies seeking to obtain a competitive advantage and compliance to various areas of GMP. We have GMP consultants to work at your site under your direction on short notice for short or long duration projects. These include: Pharmaceutical Engineers, GMP compliance consultants, Validation consultants, Regulatory Affairs consultants and Technical document writers. At Pharma arena, our goal is to help clients ensure their facility, utilities, and equipment perform as intended. We do that using a risk-based approach to maximize time and cost efficiencies through focused qualification efforts.

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