Pharmaceutical companies are subject to increasingly stringent regulatory requirements, due to their crucial role in providing safe and efficacious products to the healthcare industry. SGD Pharma offers documentation and expert guidance to ease the burden of regulation and ensure that customers can comply efficiently and professionally with all requirements.
Across the world pharmaceutical regulations safeguard the quality of approved drugs. Such regulations extend to packaging which can directly affect critical product attributes. SGD Pharma manufactures and controls its primary packaging to all relevant international standards and also applies a rigorous selection process to all suppliers, checking and confirming qualifications and performance.
SGD Pharma products are produced in facilities operating under a quality management system which is certified compliant to ISO 15378 standards and thus where GMP requirements specific to pharmaceutical primary packaging are consistently applied.
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.
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.
