Horn Pharmaceutical Consulting - Small to Medium-sized Enterprises ,SMEs, Project management, In-house trainings, Non-clinical, Drug development, Clinical trials, Pharmaceutical company, Biotechnology company, Active Pharmaceutical Ingredient ,API, Drug development, Regulatory agencies

www.horn-pharma.de Review:

http://25healthyways.com/w/www.horn-pharma.de.html

Horn Pharmaceutical Consulting - ASMF, Active Substance Master File, US-DMF, Drug Master File, Certificate of suitability, CEP, CTA ,Clinical Trial Application, IND, Investigational New Drug Application, CTD, Common Technical Document, European MAA, Marketing Authorization Application, NDA, New Drug Application / BLA, Biologic License Application, SPCs, Summary of Product Characteristics, clinical or nonclinical study protocols and reports, clinical or nonclinical summaries and overviews, quality overall summaries, QOS, CMC-documents, regulatory strategies, Authorities, EMA, FDA, GMP, GCP, GLP, quality systems, SOPs, training, pharmaceutical, biotechnology, API ,Active Pharmaceutical Ingredient manufacturer, contract manufacturer, contract laboratory, SME, Small and Medium-sized Enterprise, medical device industry, advanced therapy industry, pre-submission, submission, pre-approval, approval, post-approval phase - HORN Pharmaceutical Consulting provides regulatory and business advice to companies from the pharmaceutical, biotechnology and medical device industries.

http://www.horn-pharma.de/company.html Horn Pharmaceutical Consulting - Regulatory Authorities, Pharmaceutical industry, Regulatory documents , Product development - Provide an effective and efficient interaction between companies and regulatory Authorities from development to registration of new drugs

http://www.horn-pharma.de/industries.html Horn Pharmaceutical Consulting - HORN Pharmaceutical Consulting, Active Pharmaceutical Ingredient ,API, drug substance development, EMA, FDA, ICH ,raw materials, intermediates, drug products and excipients Pharmacopoeias, regulatory IMPD/IND MAA/NDA , Drug substance part of the CTD, Certificate of Suitability ,CEP, European Drug Master File ,ASMF, US Drug Master File ,DMF, validation, Quality Assurance ,QA - Active Pharmaceutical Ingredient (API) is the substance in a drug that is pharmaceutically active

http://www.horn-pharma.de/consulting.html Horn Pharmaceutical Consulting - regulatory requirements, marketing authorisation, regulatory strategies, regulatory Authorities EMA, FDA, CTD , IMPD/IND, Variations and changes, orphan drug applications, SMEs ,Small and Medium-sized Enterprises - Development of regulatory strategies, preparation of development plans, interaction with regulatory Authorities, preparation and conduct of meetings with Authorities

http://www.horn-pharma.de/project_management.html Horn Pharmaceutical Consulting - marketing approval, drug development, regulatory compliance , submission process , drug development , regulatory dossiers , regulatory strategies , EMA, FDA, project status reports - Preparation of project plans from early phases of drug development to submission of regulatory dossiers

http://www.horn-pharma.de/gxp.html Horn Pharmaceutical Consulting - quality system , compliance risks , SOP, Quality Assurance ,QA systems, GMP , Validation master plan , Qualification mock-inspections , FDA , EMA , Contract manufacture/Contract laboratories , Compliance checks , Pharmaceutical Ingredients ,APIs - Development of qualification and validation strategies and SOPs, planning and installation of GMP-compliant QA systems (mock inspections), consulting for pharmaceutical production, storage and labelling

http://www.horn-pharma.de/training.html Horn Pharmaceutical Consulting - regulatory requirements, marketing authorisation, regulatory strategies, regulatory Authorities EMA, FDA, CTD , IMPD/IND, Variations and changes, orphan drug applications, SMEs ,Small and Medium-sized Enterprises - General and specifically tailored in-house training in the areas of centralized, decentralized procedures, strategies for product development (MAA, NDA, BLA-submissions), requirements for (CTA) and (INDs),writing and assessment of CTD-documents, preparation of e-CTDs) and QA

http://www.horn-pharma.de/information.html Horn Pharmaceutical Consulting - Regulatory intelligence , drug development , regulatory requirements, clinical trials drug product - Regulatory intelligence focuses on the essentials in the regulatory world and keeps you abreast of what you really need to know for your development product

http://www.horn-pharma.de/clinical_development.html Horn Pharmaceutical Consulting - Clinical documents, drug development, regulatory Authorities, clinical studies, IMPD, IND, investigator’s brochure, study protocol, informed consent, clinical trial, medical writing , International Conference on Harmonisation ,ICH Study reports, CTD, EMA, FDA, CTA, MAA,NDA - Preparation of investigator’s brochures, study protocols, study reports, IMPD documents, CTD documents (e.g. Module 2.5 ), CTA and INDs application, MAA and NDA

http://www.horn-pharma.de/due_diligence.html Horn Pharmaceutical Consulting - new product, Due diligence reports, feasibility studies - Review of product development status, evaluation of product development strategy, feasibility studies

http://www.horn-pharma.de/non_clinical_development.html Horn Pharmaceutical Consulting - molecules, clinical trials, non-clinical pharmacology, pharmacokinetics, pharmacodynamics, toxicology, GLP, drug labelling - Interaction with contract laboratories, support and advice on study design, study protocols and study reports and preparation of potential regulatory agency inspections (GLP)

http://www.horn-pharma.de/gcp.html Horn Pharmaceutical Consulting - GXP , clinical studies , regulatory requirements , GCP-compliant Quality Assurance ,QA systems , mock-inspections , Clinical Trials Applications ,CTAs , Investigational New Drugs ,INDs , Marketing Application Authorisation ,MAA , New Drug Application ,NDA , Investigator’s brochures , Study protocols, Study reports IMPD documents , CTD documents , Standard Operating Procedures ,SOP , Quality Assurance ,QA audits for clinical trials , audit , clinical trials - Preparation of clinical drug development: trial design and phases, review and submission of CTAs and INDs, MAA and NDA, quality issues and audit findings in clinical trials and writing of SOPs

http://www.horn-pharma.de/glp.html Horn Pharmaceutical Consulting - FDA, EMA non-clinical development Quality Assurance ,QA , mock-inspections preclinical study , non-clinical , study design, study protocols and study reports , contract laboratories , compliance , Audit , Standard Operating Procedures ,SOPs , QA systems , GLP-agreements - Planning and installation of GLP-compliant QA systems , development of SOPs, advice on study design, study protocols and study reports, review of non-clinical documents and interaction with contract laboratories

http://www.horn-pharma.de/clients.html Horn Pharmaceutical Consulting - Small to Medium-sized Enterprises ,SMEs, Project management, In-house trainings, Non-clinical, Drug development, Clinical trials, Pharmaceutical company, Biotechnology company, Active Pharmaceutical Ingredient ,API, Drug development, Regulatory agencies - HORN Pharmaceutical Consulting clients range from small, mid-size businesses to large multinational companies

Country: 188.64.60.202, Europe, DE

City: 9.491 , Germany

C. Park - Terrible installation

After 4-1/2 hours the first day on a chat session and then another 3-1/2 hours the second and then another 2-1/2 hours the third time they were able to finally get it installed. I have used this product before and have been satisfied with it. However I will definitely reconsider it next time. I don't have any idea why after the subscription is up, if you RENEW your subscription it is over three times as much money than you can buy it at retail locations and then reinstall it. You would think that if you already are using their product and are happy enough to renew it, it would be the same, in fact, even less than you could buy it at a retail location. Anyway, think about it before you buy it.

Hazel - supersmile whitening system.

It did not do anything to whiten my teeth, after I used it faithfully. and I would not recommend it because it is a waste of money.