BioPharma Services, Inc. Successfully Completes 3 FDA Inspections with ZERO Form 483’s

Toronto, Canada – BioPharma Services, Inc. (BioPharma) is proud to announce that it has successfully completed 3 inspections this month by the US FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, Missouri.   Over the course of 2 weeks, the back-to-back inspections focused on a total of 9 studies including 4 bioanalytical validations that were conducted in support of ANDA and NDA filings to the US FDA.  All 3 inspections concluded without a 483 Form being issued as BioPharma continues to build on its impressive regulatory track history with zero observations.

BioPharma’s US-based clinical facility in Columbia, MO, underwent 2 sequential FDA inspections with impressive results.  Since our opening in 2014, the US-based clinical site has completed a number of pivotal programs to support drug submissions to the US FDA and is poised to undergo a clinical expansion to 120-beds this summer.  Following these 3 inspections across both sites, no Form 483s were issued, once again demonstrating BioPharma’s excellence and dedication to quality research.

All 3 inspections were hosted and led by BioPharma’s Sr. Management Team, Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs, Louis Co, VP of Global Clinical Operations and Dr. Nicki Hughes, VP of Bioanalytical Operations.  Under their leadership and direction, BioPharma continues to lead the industry in quality, innovation, and cost effectiveness.

“I am proud of both our teams in Canada and the US for maintaining the highest quality standards in delivering outstanding service to our clients. The dedication of our teams to provide excellent quality and timely service to our clients sets us apart,” stated BioPharma’s VP of Global Clinical Operations, Louis Co.

“The Bioanalytical audit was a success thanks to our attention to detail and highly skilled and competent laboratory team,” added Nicki Hughes, VP of Bioanalytical Lab Services.

Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs at BioPharma added, “The successful outcome of all three inspections is the direct result of hard work and dedication of our teams!   I’m extremely proud of all that we have and continue to accomplish!”

 

About BioPharma Services Inc.

BioPharma Services Inc. is a Full-Service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide.  The company has clinical facilities both in the USA and in Canada with a total bed capacity of 250 with access to healthy volunteers, special populations and patients.  Headquartered in Toronto, Canada, BioPharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.

For more information regarding this press release, please contact Ms. Anna Taylor, Executive VP of Business Development at ataylor@biopharmaservices.com

BioPharma Services, Inc. Completes Another Successful Inspection by the European Medicines Agency (EMA)

Toronto, ON – Bio Pharma Services, Inc. (Bio Pharma) ended their 10th year anniversary celebrations by announcing the successful EMA inspection of their Toronto based clinical and bioanalytical site.  The 5-day inspection which included a complete audit of their clinical, bioanalytical and pharmacokinetic units, was the first inspection conducted by the French National Agency for Medicines and Health Products Safety (ANSM) and the Danish Medicines Agency (DKMA) at Bio Pharma.  With the strong and positive outcome of this last inspection, Bio Pharma continues to build on its impressive regulatory achievements, having now completed inspections for all major jurisdictions in the global marketplace.  Bio Pharma’s outstanding regulatory history includes successful inspections by the US FDA, UK MHRA, Health Canada, Standards Council of Canada and ANVISA.

“This EU GCP audit comes on the heels of Bio Pharma successfully renewing its GLP certification with the Standards Council of Canada (SCC) just last week.  Our attention to detail and high quality is what sets us apart in the marketplace.  I am very proud of our contributions to safe and effective medicines,” stated Bio Pharma’s CEO, Renzo DiCarlo.

Andjica Tasic, Vice-President, Quality Assurance and Regulatory Affairs at Bio Pharma added: “The successful outcome of this EMA inspection was years in the making.  All of us here at Bio Pharma are committed to continuous improvement in our pursuit of excellence and executing R&D to the highest of standards.”

About Bio Pharma Services, Inc.

Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide.  With clinical facilities in Columbia, Missouri and Toronto, Canada, Bio Pharma’s total bed capacity sits at 250 with an impressive subject database of healthy volunteers, special populations (which includes post-menopausal females, hypogonadal males, and recreational drug users) and patients.  Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.

 

For more information regarding this press release, please contact Ms. Anna Taylor, Vice President of Business Development at ataylor@biopharmaservices.com

 

BioPharma Services Inc. (BPSI) announces the 2016 recipient of the Lorelei Lutter Fine Arts Scholarship

BioPharma Services Inc. (BPSI) announces the 2016 recipient of the Lorelei Lutter Fine Arts Scholarship (LLFAS) in memory of Lorelei Lutter, VP Business Development. The scholarship is meant to be a reflection of Lorelei’s love of fine arts.

“I am very pleased to award May He Tesoro with the Lorelei Lutter Fine Arts Scholarship.  May has shown remarkable talent in fine arts genre of vocalist and dancer, winning a number of Kiwanis and provincial musical awards — commented Renzo DiCarlo, CEO of BioPharma Services Inc.

final-medium

The scholarship will be awarded on September 28th, 2016 to May He Tesoro, daughter of Juan He, a Biopharma employee.

May is entering her first year at St. Brother Andres Catholic High school.  May started singing at the age of two (2) and on stage solo at age four (4).  She also plays piano and also does ballet and traditional dance. May’s future educational goals are to specialize in Human Sciences and continue her studies as a vocalist.

About BioPharma Services Inc. BioPharma Services Inc. is a physician-owned, physician-run, FDA-inspected, UK MHRA-inspected, and Health Canada-inspected International Contract Research Organization (CRO) which specializes in the conduct of Phase I/IIa clinical trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies from US, Canada, Australia and Europe. The company currently has a modern 174-bed clinical facility and a co-located bioanalytical laboratory in Toronto, Canada. The company is privately held and is headquartered in Toronto, Canada.

Contacts
BioPharma Services Inc.
Patricia Polisena, 1-416-747-8484
scholarship@biopharmaservices.com

Bio Pharma Services, Inc. Acquires Key Intellectual Property and Human Resource Assets of Bioanalytical Laboratory Services (BLS)

Bio Pharma Services, Inc. Acquires Key Intellectual Property and Human Resource Assets of Bioanalytical Laboratory Services (BLS).

 Toronto, Canada – Bio Pharma Services, Inc. (Bio Pharma) is proud to announce that it has acquired key human resource assets along with a list of validated assays from Bioanalytical Laboratory Services (BLS). Over the past 3 years, BLS, led by Lab Director, Nicola Hughes, Ph.D., has built a leading bioanalytical research centre specializing in complex method development, method validation and the analysis of biological samples for pre-clinical and clinical drug trials (BA/BE studies). BLS assets will be combined with Bio Pharma’s existing Bioanalytical Lab to further expand and fortify its analytical services and become a global leader in clinical research.

“We are very proud to combine the best of Bio Pharma’s existing bioanalytical lab with the best of BLS. Under the scientific leadership of Dr. Hughes, the expanded lab at Bio Pharma will be able to immediately offer challenging and complex new assays while strengthening our Scientific R&D team. This is just one  of a list of benefits associated with merging the assets of two great labs at Bio Pharma.” said Renzo DiCarlo, CEO at Bio Pharma Services, Inc.

Effective immediately, Dr. Hughes will be appointed to the Bio Pharma Executive Team as the Vice- President of Lab Operations. “I am extremely excited about my team joining the Bio Pharma team and believe together, by offering scientific excellence, high quality assays and our commitment to providing exceptional service to our clients, we are ideally suited for the early stage research market.”

With this news, existing BLS client projects will be honoured and completed as planned at the current BLS facility. Anna Taylor, Vice-President of Business Development reiterated, “We truly are a client centered organization driven by science and quality research. I am excited that we have this opportunity to share our expanded BA lab expertise and service for both past and future clients under this new team at Bio Pharma.”

The statements in this press release are solely expressed and made by Bio Pharma Services, Inc.

 
About Bio Pharma Services Inc.

Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. Bio Pharma has clinical facilities both in the USA and Canada with a total capacity of 250 beds with access to healthy volunteers, special populations and patients. Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis, Medical Writing and Data Management.

 
About Bioanalytical Laboratory Services (“BLS”)

Bioanalytical Laboratory Services is a Contract Research Organization (“CRO”) that specializes in the development, validation and application of LC-MS/MS bioanalytical methods for pre-clinical, non-clinical, Phase 1, and BA/BE clinical trials. The business employs a team who service clinical CROs and generic drug manufactures from BLS’ Toronto based laboratory.

 
For more information regarding this press release, please contact Ms. Anna Taylor, Vice President, Business Development at ataylor@biopharmaservices.com