Regulators in both established and maturing agencies are facing challenges in their effort to provide...
PharmaConsult Global provides advice on product formulation, indications and dosage instructions.
The company will resolve issues around products with specific difficulties and provide you with an assessment of compliance with the EU good manufacturing practice (GMP) Guidelines Vol 4 and the International Organization of Standardization (ISO) 9001, and 13485 standards.
Work begins as soon as a new drug is discovered and continues long after the product reaches pharmacy shelves. Stringent testing requirements have to be met and include accurate and detailed information along with convincing analysis and results.
Before documentation is submitted, it is down to regulatory affairs to ensure the right tests have been done at the right times, and with the correct interpretation of results.
Even when a licence to sell a new treatment has been granted, work doesn’t end there. It’s important to ensure a medicine’s packaging is accurate and informs patients about benefits and potential drawbacks.
PharmaConsult will manage the implementation of responsible labelling and packaging to ensure new treatments are effective, have minimal risks and quickly reach your market. Good labelling can safeguard against drug misuse and prevent dangerous side effects. Accurate labelling can be as much a lifesaver as the drug itself.
Regulatory GMP/GDP compliance auditing
The GMPs for the manufacture of active pharmaceutical ingredients (API) and final drug products require a full system of standard operating procedures (SOP), other procedures such as receipt, sampling, and deviation investigation, and processes such as batch records.
Pharmaconsult can help you create the systems you need for:
- Quality management
- Facilities and equipment management
- Laboratory information management
- Materials receipt, sampling, and acceptance
- Packaging and labelling
PharmaConsult Auditing services will examine your manufacturing processes and integrity of data collection systems, including:
- Carry out GMP reviews of manufacturing facilities and quality management systems
- Audit your suppliers and contractors for compliance with GMP, good laboratory practice (GLP) or other standards
- Work with your QPs and other in-house QA experts to improve presentation of facility and systems for inspectors
- Prepare response documents or appeals on your behalf
- The evaluation of the risk to quality will be based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9) and the quality management systems (ICH Q10)
Regulatory due diligence
Regulatory due diligence can be undertaken for potential licensing opportunities. Not only can PharmaConsult identify gaps in old dossiers, but it can arrange for and manage the additional studies to complete the dossier.
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