BioPharmaceutical &

Biotechnology Consulting Services

 

GXPQS is a boutique consulting company dedicated to partnerships in Biopharmaceutical Development with a unique, practical Quality System approach. We provide consulting services and assist clients in setting up phase-appropriate quality systems to Biopharmaceutical Industries developing Drug Products including Biotechnology-derived and Biologic products, Combination Products, Medical Devices, Drugs, and Vaccines in Research and Development and Commercialization phases of development.

Our Services

Quality Assurance and Quality Systems Development

GXPQS has the capability and expertise to ensure data integrity, to ensure documentation is secure and controlled

Chemistry, Manufacturing, and Controls

From Quality System SOPs for internal production operations, to laboratory manufacturing and testing we have you covered

Regulatory Affairs and Electronic Publishing

We have experience in pre-IND meeting planning to authoring, assembling, validating and submitting regulatory documents

Discovery and Preclinical Research

Our consultants are well-versed in GLP and Good Documentation Practices and can advise Clients on developing robust documentation systems

Strategic Consulting

GXPQS can also assess products lifecycle and identification of the strategic and execution elements necessary for product approval

Clinical Development /Safety & Pharmacovigilance

We can also provide specific clinical operations and medical affairs services. We can achieve this by sending our qualified physicians that offer medical management and oversight as well as project managers

GXP Training

We also can supply training materials such as agendas, detailed course notes, and supporting reference material which when completed certifies them in GXPQS

Medical Writing, Data Management, and Biostatistics

With over 10 years' experience our consultants can help you write reports for preclinical research and chemistry. This includes comprehensive medical and technical writing services in all operational areas

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Drive Ste.115-32 

The Woodlands, Texas 77382