Biotech Research Group understands the complexity of biologics development and the differences to pharmaceutical and medical device development. Our Biologics Consulting Group has experience that expands beyond FDA Title 21 CFR Parts 1271 & 1272, product development, current good tissue practices and quality compliance.

Biologics plays a vital role in the biotechnology revolution, let our biologics experts help you at every stage of your biologic product development from conception to commercialization. Our BLA Consultants can provide the following services:

  • Nonclinical testing and verification
  • Clinical trials coordination
  • Pharmacology/Toxicology
  • Total quality management
  • Biologics manufacturing
  • Good tissue practices
  • Good manufacturing practices
  • Good clinical practices
  • Good laboratory practices
  • Standard operating procedures
  • BLABiologics License Application

Our BLA consulting group will guide you through the correct protocol to prevent transmission of infections and diseases by using strict testing and plasma dilution algorithms. We can help with tissue, tissue-based products, vaccines, blood products, cellular and gene therapies and other leading biologics. Our team can help on short-notice and work around the clock to meet your internal and external deadlines. Biotech Research Group has built good relationships with CBER FDA agents, let our experience and relationships work for you.

Regulatory Strategy and Product Development

  • Conduct regulatory reviews to evaluate client’s biologics product and provides a strategy that offers their product to market the quickest
  • Provide product development design plans for biologics, small molecules, combination devices, and biosimilars
  • Perform due diligence assessments
  • Assist with nonclinical pharmacology and toxicology requirements for biologics
  • Provide Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Tissue Practices (GTP) assistance
  • Offer complete Quality Management System (QMS) implementation and review
  • Oversight for clinical trial planning and CRO selection

FDA Meeting

  • Lead or participate in formal FDA meetings
  • Prepare and assist with briefing packages for FDA and Advisory meetings
  • Engage the FDA in a positive manner to obtain the responses needed for a successful meeting
  • Write and review meeting minutes

FDA Submission

  • Analyze and assess gaps in submission requirements
  • Review, compile, write and submit BLA applications

FDA Mock Audit

  • GTP, GLP, and GCP compliance
  • Gap assessments
  • Data audits
  • Facility and personnel audits
  • FDA Mock Audit on-site or virtual

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