Regulatory Affairs services

Experience and expertise in Regulatory Affairs are fundamental to the successful applications of marketing authorisation, marketing and maintenance of pharmaceutical products. Choose a partner with specialist knowledge to navigate the regulatory complexities within Worldwide healthcare sector.

A-consult group delivers solutions that help you as a global life science company to manage the complexities of the regulatory environment in a global healthcare sector.

 

We are your partner to conduct your regulatory strategy, in order to reduce cost and increase efficiancy by maintaining quality and compliance for your products.

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Regulatory Affairs - Drugs

A-consult group provides a full range of consulting services. We can provide:

Regulatory writing (pharmaceuticals, herbal medicines, homeopathic, consumer healthcare, etc…)

  • Product positioning and regulatory strategy
  • All Modules of the MA Dossier (CTD, EU-Nees, eCTD)
  • Literature search and documentation review
  • NonClinical Overviews, Summaries & Expert Statement (Modules 2.4, 2.6 & 4 - NCES)
  • Clinical Overviews, Summaries & Expert Statement (Modules 2.5, 2.7 & 5 - CES)
  • Technical writing and Quality Overviews
  • Writing of ASMF, DMF and CEP
  • Switch core dossier, Export
  • Drug product information: SPC, PIL
  • PSUR writing and submission, evalution of AEs
  • Submission to the Health Authorities (National, MRP, DCP, International, etc)
  • Compilation of documentation for Marketing Authorisation
  • Preparation of Marketing Applications (New, Variations, Renewals, etc)

Regulatory maintenance

  • Compliance reviews and Deficiency reports
  • Conversion/update into CTD/eCTD/EU-Nees formates
  • Management of variations, line extensions and renewals
  • Advertising/labelling compliance
  • Proofreading and translations
  • Reimbursement/Price dossiers
  • User testing
  • Due diligence

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Regulatory affairs - Medical Devices

A-consult group provides a full range of consulting services for the development and registration of medical devices. We can provide:

  • Writing and evaluation of product labelling
  • Writing and evaluation of promotional material
  • Expertise in classification and evaluation of your product
  • Writing of technical dossier for Class I, II or III medical devices according to EU current regulations
  • Notification to the competent Authority

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Regulatory affairs - Food and Food supplements

A-consult group provides a full range of consulting services for the development and notification of Food and Food Supplements. We can provide:

  • Expertise in the classification
  • Evaluation of product
  • Writing of product labelling
  • Evaluation of promotional materials
  • Preparation of technical dossiers for Food and Food Supplements, according to EU current regulations
  • Notification to the Authorities.

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Regulatory Affairs - cosmetics

A-consult group provides a full range of consulting services for the development and notification of Cosmetics. We can provide:

  • Expertise in the evaluation of product
  • Writing of product labelling
  • Evaluation of promotional material
  • Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
  • Notification to the Authorities.

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