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Dr. Regenold GmbH - Biopharmaceuticals
http://www.regenold.com/regenold2014/biopharmaceuticals.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Regulatory sciences in Biopharmaceutical drug development. Antibodies and antibody fragments. Somatic cells, gene therapies, tissue engineered products (ATMPs). Herbal and Traditional Herbal Medicines. We offer a Starter Pack to help you understand the regulatory requirements and challenges for your new development. Phone: 49 7632 82 26-0. Fax: 49 7632 82 26-22.
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Dr. Regenold GmbH - Preclinical Development
http://www.regenold.com/regenold2014/preclinical-development.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Our preclinical experts have a long-standing experience in preclinical research, toxicology, and regulatory. Therefore we can help you with:. Preclinical study planning and management, evaluation and interpretation of results. Compilation of the preclinical parts of the CTD. Compilation of Investigator s Brochures and IMPDs. Regulatory Strategy and Implementation.
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Dr. Regenold GmbH - Product Management
http://www.regenold.com/regenold2014/project-management.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. We provide project management for entire projects or individual steps, including planning, organization, selection of partners, coordination, monitoring and control of the various steps of the development process. Define the product development concept. Design and implement development programmes for quality, preclinical and clinical. By gaining an understanding ...
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Dr. Regenold GmbH - Portfolio Analysis & Life Cycle Management
http://www.regenold.com/regenold2014/portfolio-analysis.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Portfolio Analysis and Life Cycle Management. Our portfolio team has over 20 years experience with blue chip pharmaceutical companies to help you build and manage your portfolio. Through our network of contacts and knowledge of available dossiers we are able to provide the following services:. Portfolio and business strategy. Post launch life-cycle management.
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Dr. Regenold GmbH - Pharmaceutical Development
http://www.regenold.com/regenold2014/pharmaceutical-development.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Our pharmaceutical development team has many years of experience in all aspects of development and are able to help you with any of the topics listed below:. Set-up of development plans. Follow-up and management of pharmaceutical development. Vendor selection and follow-up of vendors. Herbal substances and extracts. Chemical and semisynthetic drug substances.
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Dr. Regenold GmbH - Pharmacovigilance
http://www.regenold.com/regenold2014/pharmacovigilance.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Our pharmacovigilance team of experts can help you with all aspects to manage and monitor the safety aspects of your product or device to meet the required regulations. Services offered include:. An EEA-Qualified Person for Pharmacovigilance. Pharmacovigilance Quality System preparation and management. Good Pharmacovigilance Practice auditing. By gaining an under...
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Dr. Regenold GmbH - Product Expertise
http://www.regenold.com/regenold2014/expertise.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Expertise where it counts. Herbal and Traditional Herbal Medicines. Dr Regenold GmbH is specialised in development, regulatory and market access. Founded in 1994, we have helped many clients gain marketing authorisations for their product developments both nationally and internationally. Phone: 49 7632 82 26-0. Fax: 49 7632 82 26-22.
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Dr. Regenold GmbH - Quality Management
http://www.regenold.com/regenold2014/quality-management.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Which SOPs do I need to gain an import license? Our IMS team can help you. Phone: 49 7632 82 26-0. Fax: 49 7632 82 26-22.
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Dr. Regenold GmbH - Strategic Advice
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49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. Understanding the client’s issue or challenge is the starting point of all what we do. We listen, brainstorm and then recommend an appropriate strategic solution where and when required. We offer strategic advice across and within all our areas of expertise and prepare high level plans to achieve a desired objective or provide a solution to a problem. By gaining ...
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Dr. Regenold GmbH - Clinical Development
http://www.regenold.com/regenold2014/clinical-development.html
49 7632 82 26-0. Regulatory Strategy and Implementation. Portfolio Analysis and Life Cycle Management. Herbal and Traditional Herbal Medicines. We offer support with:. Consultation with regulatory authorities for scientific advice. Briefing Documentation for Scientific Advice procedures. Protocol assistance for orphan drugs. Handling of Assessment Reports. Clinical Trial planning and management, evaluation and interpretation of results. Compilation, Maintenance and Storage of Clinical Trial Masterfiles.