GMP Pharma BV. Netherlands

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1 GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation.

2 About Us: GMP Pharma BV is a multisource organization for Active Pharmaceutical Ingredients (API), Pharmaceuticals, Biopharmaceuticals, Biotechnology, Medical Devices and Food Industry. With Core Services being Outsourcing, Licensing, Validation, Auditing, Facility Client Validation and Trading it provides a single platform for cooperative and partnering business. GMP Pharma Institute, India was established in 2004 with its name as Pharma Institute of GMPs- PIGMP focuses on training, technical consultancy, GMPs, Regulatory, Auditing and Validation services. PIGMP is now a registered private limited company with its title as GMP Pharma Institute Private Limited. It has further expanded its operations in areas of development technology, manufacturing technology and analytical technology as part of its Consultancy Services.

3 Outsourcing Services: GMP Pharma BV, helps provide APIs, Finished Dosages and Pharmaceutical Excipients, for European manufacturers, at competitive price, from the Indian sub-continent. With an overall objective to minimize the cost of API supply chain, with on-time deliveries and highest quality products, from excellent manufacturing facilities, with valid GMP certification and necessary accreditations, along with available CEP (Certificate of Suitability to European Pharmacopoeia). The outsourcing is done only from the selected best manufacturing facilities based on our Quality Audits to check the Quality standards, capacities, and capabilities, to protect the interest of the European Customers. Your solutions to problems of procurement, timely deliverables, high standards of product quality, competitive cost and overall trust is assured by our experts in GMP Pharma, India.

4 Facility Client Validation Services: As per the EU GMP - Directive 2003/94/EC and Directive 2001/83/ EC, the status of GMPs for APIs will be elevated from guidelines only to legally enforced by the delegated act on the principles and Guidelines Of Good Manufacturing Practice for Active Substances in Medicinal Products for Human Use GMP Pharma BV, Netherlands coordinates with its India office, GMP Pharma Private Limited, to check the status of compliance to GMPs and status of validation of the manufacturing facilities, equipment and processes. This way it assures consistent product quality to its European clients. PIGMP has a team of experts who perform regular audits of manufacturing units and recommend Upgradation of the facilities, processes and GMP systems.

5 Auditing Services: GMP Pharma BV, Netherlands offers it s "Auditing Services" either as direct audit directly to the manufacturers for GAP analysis & general improvement or as third-party audit of the manufacturing facilities on behalf of European or North American Companies. This may cover Quality systems, Laboratory systems, Production related systems, Materials systems, Engineering systems and R&D laboratories. With its versatile expertise and more than three decades of experience on auditing/inspection and requirements of Regulatory and GMPs, it provides you with the best compliance audits/findings, GAP analysis and ready-touse solutions. Through such audits, we help the companies in upgrading Facilities, Quality Systems, Regulatory Compliance, Documentation Systems, Failure Investigation Audit, Trouble Shooting Audit, Vendor Audit, Technical Due Diligence Audit.

6 Site Variation Services: GMP Pharma BV, Netherlands in coordination with GMP Pharma Institute Private Limited, India can help in developing partnership between European company and Indian Company for APIs or Dosage Forms Site Variation Regulatory processes. This way the European partner can add a new/addition source of the API or dosage form products at competitive price without compromising on quality standards. GMP Pharma BV, Netherlands shall be responsible for the coordination while GMP Pharma Institute Private Limited, India shall be responsible for commitments to compliance with GMP & Regulatory requirements through periodic audits and checks.

7 Training Services: GMP Pharma BV, Netherlands can help organize training programs on any Pharmaceutical or Biopharmaceutical related subject through its parent organization, GMP Pharma Institute Private Limited, India. GMP Pharma Institute Private Limited, India holds an esteem position in offering several training programs in the form of conferences, seminars and workshops organized in different cities of India and abroad. These programs are organized for professionals from different Pharma and Pharma related companies. It specializes in In-house training programs for companies who are interested in customized programs to be organized for a set of people from their company. GMP Pharma BV and GMP Pharma Institute Private Limited, India can together work out training programs to help its customers in Europe and India alike. The common training programs are: Facility Designing Process Development HVAC & Water systems Microbiological Practices Quality By Design Quality Risk Management Quality Management Systems Qualifications & Validations GMPs & Quality Assurance Developing Competency Good Documentation Practices Training the Trainers for GMPs Training the Auditors for GMPs Sterilization processes Lab Controls & Lab Compliance ICH & other Regulatory guidelines Regulatory submissions & inspections Regulatory & GMP audits for compliance Technology Transfer (Process & Analytical) Aseptic Processing Advanced manufacturing & analytical technology

8 Licensing Services & Partnering: GMP Pharma BV, helps identify most appropriate strategic partner, by assessing and screening the Technical and Commercial viability, for all your Licensing needs. With an experienced team of experts from all fields to cater to APIs, Drug Product Formulations, Biopharmaceuticals, Biotechnology, Fermentations and Medical Devices, GMP Pharma BV will provide you with potential partners supporting you through the scouting of potential technologies and products. We support you with several legal structures: Merger Acquisition Assignment Distribution Alliances

9 Contact us: GMP Pharma BV, Netherlands Tel:

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