{"id":13776,"date":"2024-09-27T09:24:02","date_gmt":"2024-09-27T07:24:02","guid":{"rendered":"https:\/\/www.clarkemodet.com\/?post_type=service&p=13776"},"modified":"2024-12-17T19:28:49","modified_gmt":"2024-12-17T18:28:49","slug":"regulatory-strategy-medicinal-products","status":"publish","type":"service","link":"https:\/\/oldweb2025.clarkemodet.com\/en\/services\/regulatory-strategy-medicinal-products\/","title":{"rendered":"Medicinal Products\u200b"},"content":{"rendered":"\n
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\n Regulatory <\/p>\n

\n Medicinal Products <\/p>\n

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The pharmaceutical industry is a highly regulated sector by health authorities to maximize the protection of human health, were regulatory and quality are key factors to ensure safety and efficacy of the products. We offer a comprehensive approach to ensure regulatory compliance and quality in the pharmaceutical and biotech field, supported by a highly experienced team specializing in different product types, including new chemical entities, biologics, and advanced therapies.<\/strong><\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n\n

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\n Medicinal Products Solutions <\/p>\n

\n Regulatory technical solutions <\/p>\n

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  • Product qualification and classification.<\/li>\n
  • Preliminary advice on the regulatory framework of the products.<\/li>\n
  • Scientific advice and consultation with regulatory agencies (National Competent Authorities, EMA, FDA, Local Authorities).<\/li>\n
  • GAP analysis and regulatory strategy.<\/li>\n
  • Regulatory Roadmap: definition of key regulatory milestones in the preclinical and clinical phases for project development until commercialization.<\/li>\n
  • Advice on Preclinical, Clinical Development.<\/li>\n
  • Preparation and submission of the corresponding dossier\/technical file, support and follow-up of queries or requirements during the authorization process.<\/li>\n
  • Support in post-marketing activities<\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
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    \n Medicinal Products Solutions <\/p>\n

    \n Quality solutions <\/p>\n

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    • Design, implementation and maintenance of Quality System (GMP\/GDP).<\/li>\n
    • Revision and writing of quality objectives, quality policy, quality manual.<\/li>\n
    • Revision, drafting and implementation of the necessary working procedures.<\/li>\n
    • General and specific training in (GMP\/GDP) or on specific internal procedures and operational practices (CAPA, Complaints, Change Control, Non-Conformity…)<\/li>\n
    • Support for audits (internal audits, suppliers, third parties\/partners), revision and writing of technical agreements.<\/li>\n
    • Support and assistance with certification audits, inspections by competent authorities and notified bodies, etc.<\/li>\n
    • Support in the risk management process: risk identification, risk analyses, risk evaluation, risk control.<\/li>\n
    • Support for validations\/verifications<\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
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      \n Medicinal Products Solutions <\/p>\n

      \n Legal solutions <\/p>\n

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      • Regulatory legal consultancy related to Health Sciences.<\/li>\n
      • Legal support in the development of Clinical Trials (contracts, patient information sheet and informed consent, review of insurance policies, interaction with Clinical Research Ethics Committees, Personal Data Protection in Clinical Trials, subsequent use of personal data for future projects, use of surplus samples for research…).<\/li>\n
      • Legal support in basic research projects (biological samples, biobanks, sample collections).<\/li>\n
      • Legal advice on advertising and promotion of pharmaceuticals.<\/li>\n
      • Protection of personal data in the health field<\/li>\n
      • Legal support in sanctioning procedures related to Health Sciences.<\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \n <\/div>\n
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