Addis Pharma Tech
Addis Pharma Tech Corp. was established in 2013 by a team of highly experienced professionals dedicated to supporting manufacturing sites and producing quality drug products. Their mission is to provide elite compliance, regulatory, and technical services to pharmaceutical and biopharmaceutical clients worldwide. They have access to over 50 vetted consultants with expertise in quality assurance, regulatory affairs, analytical chemistry, formulation development, technical writing, gap analysis, remediation, and project management. The company is committed to problem-solving, delivering immediate results, and creating long-term solutions for their clients.
Industries
Nr. of Employees
small (1-50)
Addis Pharma Tech
Santa Ana, California, United States, North America
Services
Planning and execution support to move pharmaceutical projects from conception to completion, including cross-functional coordination and milestone management.
Auditing, gap analysis, cGMP review, supplier audits, mock inspections, APQR support, and remediation planning to address regulatory expectations.
Laboratory support including gap analysis, method development, method validation/verification, and execution of QC testing using chromatographic and electrophoretic techniques.
Assistance preparing regulatory documents and electronic submissions (eCTD), and authoring SOPs, APQRs, and other regulatory reports.
Planning and execution support to move pharmaceutical projects from conception to completion, including cross-functional coordination and milestone management.
Auditing, gap analysis, cGMP review, supplier audits, mock inspections, APQR support, and remediation planning to address regulatory expectations.
Laboratory support including gap analysis, method development, method validation/verification, and execution of QC testing using chromatographic and electrophoretic techniques.
Assistance preparing regulatory documents and electronic submissions (eCTD), and authoring SOPs, APQRs, and other regulatory reports.
Expertise Areas
- Regulatory compliance and eCTD submissions
- Quality assurance and cGMP remediation
- Analytical method development and validation
- GMP QC laboratory testing
Key Technologies
- High-performance liquid chromatography (HPLC)
- Ultra-performance liquid chromatography (UPLC)
- Capillary electrophoresis (CE)
- Size-exclusion chromatography (SEC)
News & Updates
We Are All Vaccinated, But We Continue To Wear Our Masks
While government officials have made the questionable decision to allow fully vaccinated people to forego wearing a face covering even when indoors, we know better. The Delta variant is rapidly spreading and even fully vaccinated citizens are finding themselves hospitalized. Our team continues to wear a face mask when in the office because the health and safety of our colleagues and their families are important to us.
Addis Pharma Opens a Field Office in Santa Ana, California
With the number of daily COVID-19 cases still dangerously high, Addis Pharma opened a field office to provide its consultants with a safer workspace. As we reopen our cities and adapt to the new normal, it is important for companies to come up with innovative solutions to help curb the spread of the virus. The field office serves as a sanctuary where our consultants can reduce their risk of contracting the virus since they aren't being exposed to large gatherings.
Addis Pharma Wraps-Up Another Successful Remediation Project in Southern California
A team of consultants helped a client bring their analytical test methods for 54 products up to date with cGMP regulations. Following a thorough gap analysis, nearly a hundred method validations or verifications were performed in under two years with just five consultants. The team was able to complete the project ahead of schedule and under budget. Another major project completed, another warning letter lifted; just an average day in the office for Addis consultants.
August 2021: We Are All Vaccinated, But We Continue To Wear Our Masks
While government officials have made the questionable decision to allow fully vaccinated people to forego wearing a face covering even when indoors, we know better. The Delta variant is rapidly spreading and even fully vaccinated citizens are finding themselves hospitalized. Our team continues to wear a face mask when in the office because the health and safety of our colleagues and their families are important to us.
May 2021: Addis Pharma Opens a Field Office in Santa Ana, California
With the number of daily COVID-19 cases still dangerously high, Addis Pharma opened a field office to provide its consultants with a safer workspace. As we reopen our cities and adapt to the new normal, it is important for companies to come up with innovative solutions to help curb the spread of the virus. The field office serves as a sanctuary where our consultants can reduce their risk of contracting the virus since they aren't being exposed to large gatherings.
Addis Pharma Wraps-Up Another Successful Remediation Project in Southern California
A team of consultants helped a client bring their analytical test methods for 54 products up to date with cGMP regulations. Following a thorough gap analysis, nearly a hundred method validations or verifications were performed in under two years with just five consultants. The team was able to complete the project ahead of schedule and under budget. Another major project completed, another warning letter lifted; just an average day in the office for Addis consultants.
We Are All Vaccinated, But We Continue To Wear Our Masks
While government officials have made the questionable decision to allow fully vaccinated people to forego wearing a face covering even when indoors, we know better. The Delta variant is rapidly spreading and even fully vaccinated citizens are finding themselves hospitalized. Our team continues to wear a face mask when in the office because the health and safety of our colleagues and their families are important to us.
Addis Pharma Opens a Field Office in Santa Ana, California
With the number of daily COVID-19 cases still dangerously high, Addis Pharma opened a field office to provide its consultants with a safer workspace. As we reopen our cities and adapt to the new normal, it is important for companies to come up with innovative solutions to help curb the spread of the virus. The field office serves as a sanctuary where our consultants can reduce their risk of contracting the virus since they aren't being exposed to large gatherings.
Addis Pharma Wraps-Up Another Successful Remediation Project in Southern California
A team of consultants helped a client bring their analytical test methods for 54 products up to date with cGMP regulations. Following a thorough gap analysis, nearly a hundred method validations or verifications were performed in under two years with just five consultants. The team was able to complete the project ahead of schedule and under budget. Another major project completed, another warning letter lifted; just an average day in the office for Addis consultants.
August 2021: We Are All Vaccinated, But We Continue To Wear Our Masks
While government officials have made the questionable decision to allow fully vaccinated people to forego wearing a face covering even when indoors, we know better. The Delta variant is rapidly spreading and even fully vaccinated citizens are finding themselves hospitalized. Our team continues to wear a face mask when in the office because the health and safety of our colleagues and their families are important to us.
May 2021: Addis Pharma Opens a Field Office in Santa Ana, California
With the number of daily COVID-19 cases still dangerously high, Addis Pharma opened a field office to provide its consultants with a safer workspace. As we reopen our cities and adapt to the new normal, it is important for companies to come up with innovative solutions to help curb the spread of the virus. The field office serves as a sanctuary where our consultants can reduce their risk of contracting the virus since they aren't being exposed to large gatherings.
Addis Pharma Wraps-Up Another Successful Remediation Project in Southern California
A team of consultants helped a client bring their analytical test methods for 54 products up to date with cGMP regulations. Following a thorough gap analysis, nearly a hundred method validations or verifications were performed in under two years with just five consultants. The team was able to complete the project ahead of schedule and under budget. Another major project completed, another warning letter lifted; just an average day in the office for Addis consultants.