Services
Pick-Two Consultancy provides a broad range of consulting services to the pharmaceutical and biotechnology industry, including:
Development and/or critical review of strategic chemistry and formulation (CM&C) plans for clinical supplies, registration or commercial production
- What to do and what not to do (i.e., ways to save money without sacrificing quality)?
- What to do first?
- What to do in-house and what to contract out?
- Identify gaps
Outsourcing strategy and tactics
- Determining the “right” scope of work
- Considering internal and external (e.g., FDA, licensing partners) customer needs
- Preparing Request for Proposals (RFPs), while protecting your intellectual property and considering commercialization
- Identify, pre-qualify, select and/or contract CROs and CMOs
- Managing progress and/or resolving issues and problems to achieve your solution
- Evaluation and/or development of supply chains
Pre- and post-commercialization supply chain planning
- Determining the "right" supply chain for the near term and for the long run
- Considering multiple factors; such as, risk tolerance, stage of life cycle, security of supply, degree of redundancy and quality assurance
- Evaluate, on your behalf, the best price and the real price
- Advise in launch preparation—timing, inventory build planning and system development (e.g., S&OP)
- Determining the "right" supply chain for the near term and for the long run
Solve organizational/operational issue and conduct due diligence
- Practical approaches to solve organizational issues, spanning drug discovery, chemistry and formulation development and manufacturing, due to growth or resizing
- Conduct due diligence, on your behalf, evaluating all aspects of chemistry and formulation R&D, and commercial product supply chains. Strong appreciation for intellectual property and its value to drug development and commercialization, along with diverse experience with a range of corporate cultures.
CMC contract review and/or negotiation
- Evaluate and/or aid in your negotiation of supply, quality and/or R&D service agreements with careful consideration of inter-dependencies between agreements, and process improvement/cost reduction incentives.
Broad-based problem solving, based on experience spanning chemical/biochemical synthesis, analytical, physical properties, formulation and scale-up/validation
- Assistance with risk management, based on good science and business considerations
Regulatory document review and evaluation
- Assessing if there is too much or not enough detail
- What are the implications to the future?
Other services include
- Process patent strategy/ligation support
- Alliance management support