Regulatory Affairs and Development
We provide regulatory affairs consulting services to the pharmaceutical and related industries in a responsible and cost-effective manner.
We specialise in the consulting in following product categories in our region and we are assisting to companies who are looking for a suitable partner, distributor or licensee to ensure a successful market introduction;
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Prescription and non-prescription medicines,
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OTC medicines,
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Pharmacy health care products.
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Natural Health products
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Cosmetics
We offer clients not just a real understanding of regulatory issues as they impact on their development, but the capability, flexibility and experience to guide programmes through to full marketing authorisation.
Our full range of regulatory services covers following list relating to regulatory affairs.
Consultancy and project management
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regulatory strategy development
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strategic planning
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expert review of data
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liaison with legal authorities
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due diligence reviews
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identifying suitable independent experts
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labelling and promotional review
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medical/technical literature searches and analysis
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medical/technical writing (clinical protocols, informed consent forms, final reports, labelling, Investigator Brochures, responses to warning letters of MOH)
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medical/technical translations (French, English)
Marketing authorisation submissions
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National Registration procedures
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Common Technical Document
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Summary of Product Characteristics
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Type I, Type II Variations
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Clinical trial applications
Post-approval
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licence maintenance variations and renewals
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transfer of ownership
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regulatory compliance
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specialists in the developments of global, regional and national integrated programs for the pharmaceutical industry in medical education, professional relations and medical communications
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File Preparation and Registration
Preparation of registration dossiers in accordance with TR/EMEA/FDA regulations
Data design (pharmaceutical development) according to the national regulations
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Patent search
Patent search and file preparation
Evaluation of pharmaceutical file
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Follow up patent applications and publications in the firm’s name
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Preparation of expert report pharmaceutics, cosmetics and medical devices
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Patent consultancy for pharmaceutics, cosmetics and medical devices
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