Business Development
Business Development services include:
- Assist clients with due diligence for license opportunities
- Business/Development Plan Development
- Fundraising assistance
- Venture Capital
- Grants
- Strategic Alliances
Due Diligence/M&A/Licensing Opportunities
Pacific BioDevelopment provides a detailed assessment of a core technology or drug programs, including an in depth critical review of existing data, reports, intellectual property and regulatory correspondence. Pacific BioDevelopment can identify potential development or marketing obstacles and provide guidance with respect to licensing negotiations, strategic partnering, drug development planning, and regulatory strategy.
Manufacturing Technology
Process Development and Manufacturing services include providing strategic and technical assessments for API and Drug Products made under cGMP for drug and biological products, including manufacturing Vialsfacility design, layout and operation. Here are some of the services Pacific BioDevelopment offers in this arena:
- Provide strategic and technical assessment and recommendations for manufacturing automation as applied to GMP cell culture operations.
- Evaluation of deep-tank cell culture processes for both development and commercial manufacturing.
- Provide recovery process strategy and advice, including purification of recombinant proteins, scale-up and troubleshooting.
- Transfer technology process to another facility or contract manufacturing organization.
- Write/review relevant sections of Chemistry, Manufacturing and Controls section.
- Provide interim management and oversight for clients without internal staff.
- Assay support and troubleshooting.
Medical Affairs
Clinical Operations
Clinical Operations services include:
- Devise clinical development strategies
- CRO selection/Audits/Transfer of Obligations
- Assess Clinical Systems for Compliance
Medical Affairs
Our Medical Affairs group provides our clients with strategic clinical advice to assist in the development of a strong medical program within their overall drug development plan. Here are some of the services Pacific BioDevelopment offers in this arena:
- Provide innovative clinical drug/biologic development strategies.
- Prepare for and participate in FDA meetings, including Advisory Committees.
- Review FDA submissions from a medical perspective.
- Provide interim management and oversight for clients without internal staff.
- Provide Clinical Operations expertise.
Operations and Project Management
Operations and Project Management services include complete operations management and product development expertise. Here are some of the services Pacific BioDevelopment offers in this arena:
- Lead project teams, and manage project budgets and timelines (new product development).
- Assist with due diligence assessments of biotechnology and pharmaceutical investment opportunities (strategic evaluation).
- Provide interim management and oversight for clients without internal staff.
Nonclinical
Early Drug Development and Candidate Selection
Evaluation of candidate molecules can involve considerations from multiple functional areas. Pacific BioDevelopment assists our clients in making these evaluations by bringing expertise in the following areas:
- Process development and manufacturing issues
- Toxicology and immunology
- Efficacy in animal models
- Pharmacokinetics and pharmacodynamics
Pharmacology and Pharmacokinetics
Pharmacology and Pharmacokinetics services include study design, conduct, data analysis, report writing and submissions. Here are some of the services Pacific BioDevelopment offers in this arena:
- Strategic development and implementation of Phase-appropriate non-clinical absorption, distribution, metabolism, and excretion (ADME) development programs in concert with the toxicology program
- Design, oversee, and analyze data for clinical and non-clinical pharmacokinetic studies
- Prepare for and/or participate in FDA meetings
- Optimize clinical dose selection using pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) modeling data
- Due diligence for in-licensing opportunities
- Draft and/or review reports and ADME sections for regulatory submissions
- Provide interim management and oversight for clients without internal staff
- Assay support and troubleshooting
Toxicology
Toxicology services include the strategic planning, design, implementation, monitoring and reporting of toxicological studies. Here are some of the services Pacific BioDevelopment offers in this arena:
- Strategic development and implementation of Phase-appropriate non-clinical programs
- Development of oral and written regulatory correspondence
- Selection and oversight of laboratory resources
- Draft and/or review internal non-clinical safety reports
- Draft and/or review of non-clinical toxicology sections for regulatory submissions (U.S. and International)
- Due diligence for in-license opportunities
- Prepare for and participate in FDA meetings
- Good Laboratory Practices (cGLP) and study monitor training
- Provide interim management and oversight for clients without internal staff
- Risk Assessment related to impurity issues or cross contamination
Quality Assurance
Quality Assurance services are divided into current Good Manufacturing Practice (cGMP) and Good Clinical Practice (cGCP)/Good Laboratory Practice (GLP) services. Here are some of the services Pacific BioDevelopment offers in this arena:
GMP
- Audit raw material vendors, control (compliance) systems, manufacturing facilities (contract and in-house), testing facilities, labeling and packaging facilities, and holding and distribution facilities.
- Evaluate validation of facility systems, equipment, cleaning and production processes.
- Review and assist in the preparation of the Chemistry, Manufacturing and Controls (CMC) sections of New Drug Applications.(NDAs), Biologics License Applications (BLAs) and Development Reports.
- Preparation for pre-approval and biannual inspections, including mock FDA inspections.
- Develop control systems and draft standard operating procedures (SOPs) specific for your company’s stage of development and consistent with cGMPs and the principles described in ICH Q8, Q9, and Q10.
GCP/GLP
- GCPPerform GCP and GLP audits and complete QA review, including reports, protocols and Investigator Brochures.
- Perform systems audits of the clinical trial safety database to assess risk management.
- Develop GCP and GLP training programs.
- Perform special fraud investigations.
- Perform due diligence investigations for regulatory and clinical trial strategy assessment.
Quality Control
Quality Control services range from providing interim management and oversight of your QC department to completing key projects. Here are some of the services Pacific BioDevelopment offers in this arena:
- Audit raw material vendors and testing facilities.
- Develop process controls and product specifications.
- Design the stability program suitable for your product and its stage of development.
- Establish reference materials.
- Evaluate test methods and methods validation.
- Assess laboratory controls and compliance.
- Provide interim management and oversight for clients without internal staff.
Validation
Validation services include developing master plans, protocols, summary reports, as well as regulatory submissions. Here are some of the services Pacific BioDevelopment offers in this arena:
- Design Phase-appropriate validation strategies for new products, processes, and facilities.
- Evaluate existing validation programs against current regulatory expectations and guidance documents and develop strategies to achieve compliance.
- Benchmark against current industry practices for validation including risk-assessment and implementation of Quality by Design (QbD) concepts.
- Provide training and conduct mock audits in preparation for regulatory inspection.
- Provide interim management and oversight for clients without internal staff.
Regulatory Affairs
Editing and Electronic Submissions
Editing and Electronic Submissions services include all aspects of coordinating and preparing regulatory documentation. Here are some of the services Pacific BioDevelopment offers in this arena:
- Develop strategies for producing paper and electronic Investigational New Drug (IND) and drug product market applications consistent with current U.S. and the International Committee on Harmonization (ICH) guidelines.
- Edit documents for optimum presentation to facilitate agency review, and to provide consistency with supporting documents.
- Provide training in the development and use of templates for paper and electronic drug marketing submissions.
- Provide interim management and oversight for clients without internal staff.
- Provide a secure environment for remote document sharing and collaboration using SFTP.
- Pacific BioDevelopment is partnered with Omnicia, Inc. for Electronic Publishing solutions and is 21 CFR Part 11 Compliant.
Labeling and Promotional Materials
Labeling and Promotional Materials services cover all aspects of label and promotional material development, including negotiations with both DDMAC (drugs) and APPLS (biologics) committees. Here are some of the services Pacific BioDevelopment offers in this arena:
- Assist with the development and implementation of systems and procedures for investigational and commercial labels/labeling, promotional, and educational materials review and approval.
- Assist with the establishment, implementation, and reporting procedures for NDC Drug Listing systems.
- Assist with the development and implementation of launch plans and strategies for advertising, press releases, sales brochures and formulary kits, including vendor selection.
- Assist with the development and strategies for pre- and post-approval activities, including conventions and press materials, and FDA pre-clearance strategies.
- Perform training for regulatory, marketing, corporate communications, and field sales and establish promotional review systems.
- Review website design and content for compliance.
- Provide interim management and oversight for clients without internal staff.
Regulatory Affairs
Regulatory Affairs services include a wide range of regulatory affairs guidance and expertise to facilitate effective interactions with regulatory authorities in order to accelerate drug development. Here are some of the services Pacific BioDevelopment offers in this arena:
- Provide innovative drug/biologic development strategies to meet corporate goals.
- Provide strategic guidance, personnel training, and expert review of regulatory submissions.
- Provide interim management and oversight of your Regulatory Affairs department.
- Accompany you to meetings with regulatory authorities to represent you or to provide impartial outcome analyses.
- Perform due diligence assessments for in-licensing opportunities.
- Serve as a US Agent for foreign companies