With 30 years of expertise, we specialize in delivering cGMP services essential for IND/BLA/NDA applications and commercialization. Our cGMP/GLP services offer:

  • Unmatched quality
  • Prompt timeliness
  • Cost-effective solutions
  • Exceptional communication
  • ALCOA+ Quality Services

Our Quality Management Systems are implemented to support the FDA compliant analysis through the product life cycle, including validation, drug release and stability.

We maintain direct interactions with the FDA, both independently and through our clients.

 

What is cGMP?

cGMP, or current Good Manufacturing Practice, refers to a set of regulations and guidelines enforced by regulatory agencies, e.g. FDA and EU. These cGMP standards are required for bioactivity testing to ensure that drugs consistently meet quality requirements. cGMP regulations are vital for guaranteeing the safety, quality, and efficacy of pharmaceuticals, medical devices, and other regulated products.

Why Choose MarinBio for Your GMP Services? 

We have over thirty (30) years of experience in helping clients, starting from

  • testing ideas to
  • development and validation to
  • IND/NDA/BLA application to
  • Stability and lot release to
  • Commercialization of drug

Need Help or Have Questions on GLP/GMP Services?

Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study,  lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services

We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.

Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.

MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.

Need help or have questions on cell based assays?

Give us a call at 415-883-8000

Implementation of cGMP at MarinBio

MarinBio has implemented ALCOA+ Quality Services such as:

  • Quality Systems Policies (QSP)
  • Standard Operating Procedures (SOP)
  • Contemporaneous Documentation for Traceability
  • Validation of Systems
  • Facility and Equipment design & maintenance integrating product

quality and productivity

  • Subject Matter Expert training
  • Supplier Evaluation & Approval to minimize risk
  • Ensuring Compliance & reviewing complaints
  • Maintaining data integrity & audit trails
  • Abiding by the Codes of Federal Regulations (CFRs):
  • 21 CFR Part 11, Electronic Records; Electronic Signatures
  • 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies

 

Marinbio ensures full communication and understanding of your needs.  We develop and validate the appropriate bioassay for potency lot release and maintain supplies for consistent assays throughout the project cycle. To fit your timelines, we perform lot and stability assays and can defend the science to the FDA. We will submit reports suitable to  your company and regulatory needs.

GMP Services Offered by MarinBio

Contact Us about Our Cell Based Assays Services

For More Information about our cell based assay services, please use the following informational form