In-Process & Lot Release Testing Services

Your Full-Service Partner

Pharmaceutical process validation testing or re-validation is necessary when you initiate a new process, change a piece of equipment, or adjust your product formulation. BA Sciences has extensive experience performing drug product testing to support process validation to meet regulatory guidelines. Once the process is fully validated, BA Sciences provides agile lot release testing to support timely product release while ensuring the identity, purity, potency, and safety of your products. Our team delivers fast, accurate results to meet the demands of time-sensitive testing requirements.

BA Sciences’ comprehensive testing capabilities help minimize delays in the manufacturing and release of your products. We support the timely release of each product lot through efficient scheduling, rapid turnaround times, clear client communication, and thorough detailed documentation. All BA Sciences drug product testing is performed in accordance with applicable GMP requirements and established FDA criteria.

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Comprehensive Expertise for Testing

When you choose us to be your partner for pharmaceutical lot release testing, your operations can benefit from our extensive range of capabilities and comprehensive expertise. We can be your complete resource for in-process batch release testing of pharmaceuticals as well as numerous other related services. These offerings have enabled us to serve customers around the world.

We have the facilities, equipment, and experience to provide:

  • Process Validation
  • GMP Lot Release Testing
  • Stability Testing
  • Cleaning Validation
  • Extractables & Leachables
  • Microbiology
  • Raw Material Testing
  • Nitrosamines Analysis

Why Should You Work with BA Sciences?

We hold numerous credentials, including an ISO/IEC 17025 Certificate of Accreditation for pharmaceutical product testing. In addition, we also have a cGMP-compliant, FDA and DEA registered laboratory just outside of Boston in Salem, NH. This reflects our capabilities and expertise in analytical testing services, including lot release testing. Clients choose BA Sciences not only for our technical expertise and certifications, but also for our personalized, results-driven approach to delivering solutions that meet their specific needs.

Every client is given a dedicated project manager who serves as the primary liaison throughout every stage of the process. Working closely with your team, the dedicated project manager develops and oversees the testing plan, ensuring it is executed successfully and in accordance with applicable regulatory requirements. Our services provide comprehensive quality assurance, helping confirm that products meet the critical quality attributes necessary to support their safety, quality, and efficacy. This commitment to rigorous testing and personalized project management is a key reason pharmaceutical companies worldwide trust BA Sciences’ expertise and processes.

To learn more about our capabilities, get in touch with us today and speak with one of our knowledgeable representatives.

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