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-pharmaconsult 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.

Regulatory Affairs - Drugs

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

Regulatory writing (pharmaceuticals, 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

Regulatory affairs - Medical Devices

A-pharmaconsult 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

Regulatory affairs - Food and Food supplements

A-pharmaconsult 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.

Regulatory Affairs - cosmetics

A-pharmaconsult 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.