OUR SERVICES

EMRC offers professional advice and assistance in the following areas:

Pharmaceutical Regulatory Affairs

• National and European Mutual Recognition and Decentralised Marketing Authorisation Applications - from compilation through to completion/approval
• PA and MA renewal applications
• Variations and Maintenance of Marketing Authorisations
• Preparation of Medicinal Product Labels and Patient Information Leaflets (PIL’s) in line with Title V of EU Directive 2001/83/EC (as amended) using EMEA QRD templates
• Review of compliance with Braille requirements on Pharmaceutical Packaging
• Conducting market compliance audits incorporating the activities of Regulatory Affairs, Sales and Marketing and Quality Assurance to ensure compliance with required quality management systems, regulations and registered files
• CTD Dossier conversion

 Wholesale and Manufacturing Services

• Submission of licence applications, renewals and amendments
• Quality control-organisation and advice
• Quality Assurance Training on all aspects of a quality system including training, documentation control, change control, pharmacovigilance and complaints, corrective and preventive action plan
• Qualified Person services
• Compliance training and review of procedures for grocery wholesalers handling medicinal products in line with current guidelines and regulatory requirements
• Compliance training and review of procedures for cosmetics wholesalers in line with current guidelines and regulatory requirements
• Compliance training and review of procedures for medical device wholesalers in line with current guidelines and regulatory requirements
• Third country importation of medicinal products
• Exempt medicinal product handling and compliance with regulatory requirements

 Medical Devices

• Medical device registration
• CE marking
• Liaison with Notified Bodies/Competent Authorities 

 Food Supplements and Cosmetics

 Food Supplements

• Interpretation of legislation in relation to food supplements
• Reviewing Food supplement labels/advertising for compliance with regulations
• Review of ingredients and Recommended Daily Allowances against Directive Schedules
• Notification to the Food Safety Authority of Ireland (FSAI) of intention to launch a food supplement onto the market

Cosmetics

• Interpretation of legislation, as it relates to cosmetic products
• Reviewing cosmetic product labelling for compliance with the Directive
• Review of ingredients against published Directive schedules
• Assessment of marketing and promotional material to ensure compliance
• Compilation and/or Technical review of Product Information Files (PIFs)
• Notification to the Health Services Executive of launch of a new cosmetic product

 Other services include:

• Product Datasheet, Summary of Product Characteristics (SmPC), Labelling, Patient Information Leaflet and Promotional Material Preparation in line with current guidelines and regulatory requirements
• Compliance check on all medical information and promotional material
• Review of Ingredients, Classification and Registration of Homeopathic and Herbal Medicinal Products in compliance with current legislation
• Training courses in Regulatory Affairs for PA holders, distributors, agents and manufacturers
• Information service: regulations, medicinal products, market analysis