Provide consultation, development, training, and review services for:
Provide PIND meeting requests and packages, IND submission ready applications, DMF submission ready
applications, PNDA meeting requests and packages, NDA submission ready applications, and ANDA
submission ready applications. Important to focus on different aspects between NDA and ANDA
applications (sterile & non-sterile).
On-site study monitoring during clinical studies Phase I, II, II ,IV studies.
Manufacturing changes are unavoidable and making the correct assessment and supplement submission
planning can bring supply chain back on schedule.
Drug product approval and product launch have mandatory post-approval commitments, such as a annual
report via change control and adverse event pharmacovigilance program design based on system organ class.
Depending on company size, goals, and upcoming approvals; SOPs can be developed and implement
differently. The most important function of SOPs is to provide easy to follow procedures that do not slow
down R&D or Supply Chain.
An effective on-site data integrity audit gives a proper assessment on were a company stands. Every company
regardless of should have an independent risk assessment whether for partnership of new drug launch, API
facility readiness, clinical study site capability, application readiness, pre-approval readiness, manufacture
controls for handling deviation and laboratory investigations (including any outside contract firm), product
release assessment, and controlled substance accountability.
Data Integrity Audits depending on the overall risk should be performed at the raw data entry notebook level or
can be performed based on current managerial planning. Provide independent PQA (Product Quality
Assessment) and CEP (Compliance Enhancement Plan) reports to District Office.
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