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
- Responsible 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)
- Registration of cosmetic products of the Cosmetic Products Notification Portal (CPNP)
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
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