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Biologics

​Biologics is a biopharmaceutical, also known as a biologic medical product, is a product manufactured in, extracted from, or semi-synthesized from biological sources. Biologics are products produced from variety of natural sources - living organisms or contain components of living organisms - human, animal, or microorganism.


Biologics can be composed of sugars, proteins, nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Most biologics are complex mixtures that are not easily identified or characterized. Biological are produced by using biotechnology methods and other cutting-edge technologies, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.


Biologics treat a broad range of common as well as rare diseases and include vaccines, cell and gene therapies, tissues for transplants, and more. Biological products include a wide range of products such as vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Gene-based, cellular biologics, regenerative medicine product, and tissue-engineered products are at the lead of biomedical research. Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available. 


 Compliance, Regulatory Strategy and FDA Submission

  • Evaluate and provide guidance on all aspects of regulatory strategy for product development
  • Advise on regulatory options and potential pathways
  • Perform due meticulousness assessments
  • Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
  • Assist with preparations for FDA and Advisory meetings
  • Author, review and publish original IND, NDA, BLA, MF, and OD applications, amendments and supplements
  • Provide clients with an ‘FDA style’ review of submissions
  • Represent clients in interactions with FDA
  • Create or assist with the refinement of regulatory strategy


CMC Development

  • Regulatory, Quality Assurance and Compliance services
  • Quality-based manufacturing and analytical method development
  • Validation
  • Formulation development
  • Assessment and evaluation of stability data and requirements
  • Preparation and review of regulatory CMC submissions
  • Risk-based strategies for product development and Management
  • Oversight of contract services
  • Design, implementation and upgrade of manufacturing systems covering a range of products


Nonclinical Development

  • Provide strategic plan for Nonclinical studies for biologics
  • Nonclinical program review and strategic support for FDA submissions
  • Early-stage development planning assistance
  • GLP consulting, oversight and compliance
  • Safety assessments for biologics
  • Review of study protocols and reports for scientific merit and regulatory compliance
  • Non-clinical CRO selection and oversight support


Clinical Development

  • Clinical gap analyses, product development/manufacturing plans, and due diligence assessments
  • Clinical regulatory expertise for products in all stages of clinical development
  • Strategy and guidance for IND, NDA and BLA efforts, including FDA meeting requests, briefing packages, preparation, and attendance, and preparation of the clinical portions of applications
  • Support for ANDA and 505(b)(2) applications
  • Authoring of initial pediatric study plan (iPSP), fast track/breakthrough therapy requests and orphan drug designation requests
  • Phase 1-4 clinical protocol development
  • “FDA style” clinical data review
  • Clinical trial support for biologics – Clinical trial planning and oversight of studies conducted by CROs or individual investigators, including CRO selection and contract negotiation, clinical operation tasks and timelines, investigator/site selection, site training, preparation/review of study documents, medical monitoring and DSMB organization


Audits

  • GMP and GLP facility and GCP compliance
  • Gap assessments, Pre-Approval Inspection (PAI) readiness
  • Commercial readiness
  • Data audits (integrity and validation)
  • Computer systems validation and Part 11 compliance

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