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REGULATORY

 

When it comes to understanding regulatory compliance and/or regulatory affairs Rita has expertise in both areas.    Whether you need to understand and decipher regulations pertaining to the requirements for cGMP compliance, or for the appropriate regulatory filing based on the development phase of your products, or need to work your way through filing deficiencies, 483's, and/or Warning Letters, Rita can help you navigate successfully.   There are many milestones and activities that need to be met before a drug product receives regulatory approval.

REGULATORY AFFAIRS

 

Do you need help with navigating and/or understanding regulatory requirements for the various drug development and commercial phases?  Need to justify method or specification changes for post-approval changes?

 

  • CMC analytical requirements for Phase I, II or III INDs, NDAs, ANDAs, or Drug Master File (DMF) regulatory filings

  • Mitigate and minimize the risk of receiving regulatory filing deficiencies, and respond appropriately to any received.

  • Post-submission/approval changes (CBE0, CBE30, Prior Approval) pertaining to analytical methods,  specifications, and/or stability data.

  • Understanding the impact of proposed manufacturing or product changes to any of the already filed/approved analytics and/or specifications.

    • ex: API supplier, formulation changes, manufacturing process, raw materials, etc.

REGULATORY COMPLIANCE

 

Compliance pertaining to analytical laboratories and the manufacture of cGMP pharma drug substances and drug products:
 

  • cGMP laboratory audits and inspections

  • Implementation of cGMP qualified analytical laboratories (R&D and QC)

    • IQ/OQ/PQ and Calibration activities required

  • Standard Operating Procedures (SOP)

  • Out of Specification (OOS) and Atypical analyses and investigations

  • Corrective and Preventative Actions (CAPA)

  • Deviations and tracking

  • Appropriate Documentation Requirements

  • Qualified Stability Storage Chambers and Stability Programs

  • Qualified Reference Standard Programs

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