Quality

OmniChem’s quality management system focuses on continuous improvement. We accomplish this through routine reviewing and trending of operational metrics with the senior management team and developing actions to drive optimization of processes.
We are proactive in our communication with regulatory and industry organizations in regards to industry improvements and establishing policies.

We take a collaborative audit approach with our customers and encourage feedback and suggestions.
We strive to provide our customers with a strong yet flexible strategy and show our customers that we are inspection ready at all times. This approach nurtures open communication and allows us to maintain a culture of transparency.

OmniChem maintains an impressive and successful regulatory track record.

We maintain this impeccable track record using internal audit teams, regulatory agencies and customer inspections.
OmniChem hosts more than 30 customer audits a year and has had over 44 Qualified Person (QP) inspections from governmental bodies of countries such as USA, UK and Japan.

Frequent audits and inspections refine the quality of our programs and further warrant the compliance of FDA’s cGMP and EU regulations.
Our Regulatory support team has authored numerous IND/NDA/BLA/eCTD submissions and is ready to help with your regulatory submissions, clinical filings and commercial launch.

OmniChem Approach to Regulatory Excellence

  • Continuous improvement philosophy- trending, quality metrics, management review
  • Quality policies, standards and well-defined SOPs in place
  • Contract with GMP qualified vendors
  • Dedicated staff for internal audit compliance programs
  • Current cGMP training programs
  • Constant inspection from customers and regulatory agencies
  • Multinational Compliance Program
  • Internal Calibration, Validation, QC Chem, QC Micro, Doc Control
  • Work with a highly trained and experienced staff
  • Transparent communication with customer
30
QA audits per year
23
FDA Inspections since 1978
21
Other GMP Inspections