SGD Pharma has registered Drug Master Files (DMF) for its Glass Primary Packaging with the relevant regulatory authorities at the United States Food and Drug Administration (US FDA), Health Canada, and the National Medical Products Administration (NMPA, formerly the Chinese FDA).
Letters of Authorization (LOA) are free of charge and are issued promptly to all customers upon request.
OUR REGULATORY EXPERTISE
SGD Pharma’s expert team delivers gold standard regulatory-related support and maintains a proactive regulatory watch. Experienced and knowledgeable, these experts are active and valued members of major associations and committees such as FEVE (the European Federation of glass packaging makers), PDA (the Parenteral Drug Association), and AFNOR (Association Française de Normalisation/French Standardization Association), enabling them to offer an unrivalled level of assistance.
Working hand-in-hand with customers our experts ensure that all the necessary support and documentation is provided during regulatory file submissions and the preparation of drug dossiers, including compliance certificate provision. Support extends from initial regulatory product assessment through to the authority approval process, accelerating drug submissions, wherever they are being made. Offering an authoritative voice in all regulatory matters our expert team is in daily contact with regulatory agencies across the globe, including the US FDA, Health Canada, and NMPA.