Drug Development

We are a small organization priding ourselves on offering timely, quality, and cost effective services in the pharmaceutical industry.

Preclinical Drug Development

  • Development of a TPP (Therapeutic Product Plan)
  • Planning, costing, and management of the drug development process
  • Interaction with the FDA to facilitate human and veterinary pharmaceutical registration
  • Preparation and submission of pre-IND packages
  • Preparation of preclinical documents for IND submission
  • Toxicology, pharmacokinetic, and pharmacodynamic study planning, placement
  • Evaluation of in-license pharmaceutical candidates

Chemical and Biological Manufacturing

  • GMP audits and inspections
  • CMC document preparation
  • Formulation Development
  • Product and Material Sourcing: including finished goods and third party sourcing
  • Product Source Selection: identification and evaluation of external capabilities versus pipeline requirements; selection of outside support; evaluation of manufacturing facilities and outside companies, preparation and negotiation of contracts
  • Streamlining of development to commercialization times through evaluation of needs and resources, identification of alternatives and management of process
  • QA/QC monitoring

Clinical Drug Development

  • Preparation of Investigator Brochures, clinical protocols and clinical trial reports
  • Preparation of clinical study manuscripts for publication
  • Placement and management of Phase I studies
  • Experience getting biosimilars through the FDA
  • Preparation of Investigator’s Brochure

Preclinical Biological and Safety Assessment

  • Early candidate profiling and screening
  • Protocol development
  • Study placement and monitoring
  • Report writing and review
  • IND preparation, review and filing
  • FDA presentations and interactions
  • Small molecules
  • Biologic
  • Combination
  • 505(b)(2)
  • Gap analysis

Leachables and Extractables

  • Design and evaluation

Degradant, Residual Solvent, Excipient, and Impurity Evaluation and Qualification

  • QSAR analysis using DEREK and Leadscope
  • Full literature reviews – GCS has its own extensive library and databases plus access to multiple other information sources. View List of Compounds Assessed.
  • Expert opinion letters

Post Approval/Marketing Support

  • Scientific review of marketing materials
  • Marketing training programs/seminars
  • CPSC Poison Prevention Act assessments and letters
  • Physician awareness lectures