Home » About Us » Our Services Our Services Strategic Planning for Product Development Advice on EU legislation Critical path analysis of R&D programmmes Strategy for entry into Europe Orphan medicinal product designation Applications for CHMP and National Scientific Advice Registration Writing chemistry/pharmacy(CMC) section Preclinical and clinical modules Preparation of regulatory submissions for MAA Expert reports / overviews EU Centralised, Decentralised, National and Mutual Recognition Procedures Liaison with EMEA and National regulatory authorities Manufactures and Wholesale Dealers Licenses Herbal Medicinal Product Authorisation Herbal Food Supplement Approval Other Services Drug master file Device master file Vaccine antigen master file Plasma master file Management advice on setting up new regulatory affairs departments Ad hoc regulatory consultancy In house regulatory consultancy SOP writing Assistance with regulatory audits and inspections

Scientific Data Assessment Assessment of data for suitability for registration Identification of deficiencies Regulatory and technical due diligence Medical Devices CE Marking Product Classification Preparation of technical files Risk assessments International Regulatory Desk Research Identification of worldwide regulatory requirements On-line literature searches International network of local advisors Training and Seminars Individual training of regulatory affairs staff Customised in-house seminars on regulatory topics Chemicals Implementation of REACH regulations Chemical registrations under REACH project

Product Literature and Readability Testing SPC, PIL and Labelling Texts Artwork creation Readability testing Publishing and Submissions Management eCTD, non-eCTD electronic and paper submissions Standalone publishing or as part of integrated regulatory project management