Informatics What does it encompass* What is excluded*
  • Reflective sharing of ideas.
  • Expression of opinion based on one’s expertise and experience on the idea.
  • Quick literature searches to support any critical question to move forward on a conclusion on the idea.
  • Discussions usually held under a non-disclosure agreement.
  • Paid database searches. Procurement of API or Reference samples and their analysis.
  • Any experimentation unless it involves readily available materials and equipment at personal disposal.
Idea validation
  • A systematic collation of relevant  literature, Open literature, Patents, News items, market data etc.,
  • Refinement of various aspects of the idea based on deliberations.
  • May generate provisional IP wealth
  • A strategy to execute the idea.
  • Experimentation unless the API  and reference products are readily available
Project strategy plan
  • IP, regulatory, Analytical, Formulation, Biostudy, Scale up , manufacturing, supply chain details, their timelines and costing, Potential partners for contracting,
  • An overview of how the CMC dossier will look like
  • Signing up of contracts, negotiation and any material purchases ,
  • No experimentation,
  • No procurement
Proof of feasibility What does it encompass* What is excluded*
  • Carefully plan experiments that generate confidence on the achievement of proposed strategy.
  • Preliminary compatibility of drugs and excipients.
  • Analysis of relevant APIs from shortlisted source. Analysis of relevant reference products.
  • proposal of  theoretical prototype formulations and  dosage forms
  • Prototype  design, manufacture and their  evaluation
Reverse engineering
  • Systematic characterization of the innovator – API type, crystallinity, excipients present (qualitative and quantitative, dissolution, mechanistic properties, etc.)
  • Prototype preparation
Formulation screening
  • Preparation of prototypes of the dosage form as per the strategy.
  • Iteration of prototype modifications to get the relevant end point evaluation data set forth in the strategy.
  • Generation of stability data in proposed packs in accelerated conditions of 40 deg C/75 % humidity.
  • Generation of data to support provisional IP
  • Larger batch sized prototypes
Prototype selection and finalization
  • Careful shortlisting of one or more promising prototypes from previous steps with promising evaluation endpoints.
  • Establishing repeatability, reproducibility and tweak ability of these prototypes in appropriate batch sizes that provides confidence of scalability. Multimedia and more elaborate evaluations to establish confidence on prototypes including stability.
  • Establishing cost – effect relationships on process
  • GMP batches, large scale up batches, Establishing Design space through DoE.
Proof of concept What does it encompass* What is excluded*
Formulation optimization (QBD steps and mini  Scale up – leading to  validation of  prototype formulae and its process )
  • Challenging the unit formulae qualitative and quantitative to establish the robustness of formulae.
  • Challenge of processing conditions to arrive at the most optimum process condition.
  • Generation of QBD section of dossier.
  • Mini scale up batches which may vary from one kg to about 50kg depending upon formula and process.
  • Multimedia dissolution data on most  promising prototype and near final process for bio outcome confidence
  • GMP batches
  • Full scale submission batches
  • Full scale  documentation for manufacturing of the batches
Bio batches (GMP batch for pilot PK study- to establish PoC )
  • Execution of final prototype with documentation in GMP facility.
  • Packaging in proposed final packs and monitoring stability in accelerated and real time as per regulatory protocol
  • No bio study dosing.
  • Dossier preparation for submission
pK study
  • Finalization of Pk study protocol.
  • Identification and signing up with CRO.
  • Dosing as per protocol.
  • Review of Bio analytical process and data
  • No Pivotal study for submission unless previously planned.
pK study result evaluation
  • Data analysis of Pk study outcome.
  • Establishing cause -effect relationship between a formulation variable and pharmacokinetic parameter.
  • Look for IVIVC correlations. Evolve suggestions for next prototype iteration and/or changes to pivotal batches to assure positive outcome in the next pK study.
  • Investigative testing of prototypes
  • Execution of pivotal batch and pivotal bio study
Chemistry, Manufacturing & Control(CMC) What does it encompass* What is excluded*
Scale up  Design space (DOE)
  • The finalized prototype composition is scaled up to proposed manufacturing batch sizes and in the final machinery for evaluation of composition and process robustness.
  • Design of experiments, powered by appropriate statistical tools, is used to establish design space of operation within which the product quality parameters are assured.
  • More QbD data is generated such as hold time, recyclability, unforeseen electro -mechanical breakdowns, alternate vendors, change of machineries, etc.
  • Appropriate batches are also submitted to stability monitoring.
  • Validation data generation, clinical & manufacturing supplies,
Clinical batches & stability data
  • Preparation of documentation for execution of clinical batches – including specification setting, master formulae, stability protocol, cleaning protocol, etc.
  • Analytical method validation.
  • Cleaning validation for area and machinery.
  • Raw material and packaging material analysis clearance.
  • Execution of batches and quality control release.
  • Packaging and stability charging as per protocol.
  • Biostudy dosing and monitoring.
CMC Dossier
  • Compilation of data and documents for filing with desired regulatory authority compliant with their requirement.
  • Sections include pre-formulation, product development, stability, packaging, specification setting, etc.
  • Dossier made ready to file.
  • Filing with the authority
Bio What does it encompass* What is excluded*
Clinical strategy (Pk/ clinical end points)
  • Appropriate pharmacokinetic and / or clinical study strategy for regulatory discussion/ controlled correspondence.
  • Detailed protocol for study execution.
  • Clinical study
Study result evaluation & IVIVC
  • Data analysis of Pk study outcome.
  • Establishing cause -effect relationship between a formulation variable and pharmacokinetic parameter.
  • Look for IVIVC correlations.
  • Evolve suggestions for next prototype iteration to ensure positive outcome in the next pK study.
  • Investigative testing of the test and reference samples.
  • Establishing in vitro in vivo correlation for the prototype performance
Intellectual Property What does it encompass* What is excluded*
Generic product development strategy
  • Collation of open and patent literature.
  • Evolution of product development strategy.
  • Experiments to validate proposal
IP Fencing / new product development strategy
  • Compilation of relevant literature for the target product profile.
  • Identification of potential innovation steps. Detailed search relevant to the innovation steps. Write up for provisional patent filing.
  • Platform technology protection
  • Application filing with patent office.
  • Prosecution
Technology What does it encompass* What is excluded*
New technology development to solve a problem of customer
  • Unmet need identification by studying the customer and market.
  • Converting the unmet need into a target product profile document.
  • Scouting for technology in neighbouring scientific fields to solve the unmet need – collaboration with interdisciplinary experts.
  • Establishing proof of concept through prototyping. Generation of IP wealth.
  • Evolve business proposal for investor presentation.
  • Capital investment
In our professional network we have the following experts whose services/ inputs can be obtained.
Collaborative expertise What does it encompass*
Market research data
  • Collation of relevant market data.
  • Analysis of data for specific query, inference and output.
  • Projection analysis of potential market opportunities.
  • Landscape reports.
Regulatory pathway proposal
  • For complex ANDA’s requiring clinical endpoints and IND filings, the complete regulatory pathway proposal for a pre meeting with the concerned FDA.
  • Proposals for therapeutic areas like Neurology, cardiovascular, oncology, metabolic diseases, etc.
Due diligence for acquisition
  • Technical assessment of the portfolio of products, pipeline, intellectual property, R&D, manufacturing infrastructure for acquisition assessment.
  • Our professional network includes several manufacturing facilities for various kinds of dosage forms and technologies.
  • Appropriate business agreements can be structured to harness these resources.
Quality & Compliance
  • Our network of professionals includes qualified experts in evaluation of facilities, dossiers, systems, and personnel for compliance to global quality standard expectations.
  • Specific compliance to USFDA expectations and hand holding mechanism to ensure upgradation is available to assure all time audit readiness.
3D Printing
  • Industrial, Pharmaceutical & Biomedical
  • Digital imaging – positive / negative image flips – high resolution object creation
  • Metal, plastic, powder, resin, biomaterials printing.
  • Desktop and industrial printers, standard & customized
Data Science
  • Big data processing
  • Mathematical modelling of data and systems
  • Research based systematic data creation for process understanding
  • This is a broad guideline and will change based on discussion with clients