Our Offerings
At TaP/Axar, we offer a comprehensive range of product development services tailored to meet your unique needs, covering every facet of the pharmaceutical Drug Product Development landscape. From Pre-formulation to Regulatory including Product Development (Formulation, Process, Package and Analytical), Intellectual Property Management, Portfolio Development, Clinical Pharmacology and Biopharmaceutics, Project Management, Quality Assurance and Regulatory Solutions, our adaptable service range ensures seamless progression through every stage of the drug development lifecycle. With a focus on the quality, we guide your projects from initial concept to successful commercialization in a time and cost-efficient manner with precision and expertise.
Formulation Technology Platforms:
Our expertise across various dosage forms and therapeutic areas ensures cutting-edge, QbD-driven solutions tailored to meet diverse pharmaceutical needs.
Ophthalmic*:
Multidose and Unit Dose Preserved and Preservative Free, Solutions, Suspensions, In Situ Gel Forming and Semisolids.
Nasal*:
Multidose and Unit Dose Preserved and Preservative Free Solutions, Suspensions Dry Powder, In Situ Gelling and Gels
Inhalation*:
Pressurized Metered Dose Nasals (pMDN), Nebulized Resuples and Pressurized Metered Dose Inhalers (pMDI), Dry Powder Inhalers (DPI) and Nebulized Respules (Blow Fill Seal)
Complex Injectables*:
Multidose and Unit Dose Pre-Filled Syringes, LyphoIlised Powders, Solutions, Suspension, Micro Sphere, Particulate, In Situ Gelling and Gels for Subcutaneous and Intramuscular Sustained Release Injection
Oral Liquids:
Multidose, Unit Dose, Palatable (Taste Making), Immediate and Extended Release, Dry Powders for Solutions/Suspensions, Liquid Solutions, Liquid Suspensions, Emulsions, Nano-Emulsions
Topicals:
Semisolids, and Liquid Formulations
Oral Solids:
Immediate and Extended-Release Tablets, Soft & Hard Gelatin Capsules with expertise in Multiparticulates, and Solubility Enhancement thru Amorphous Solid Dispersion and Lipid -Based Formulation Development.
Medicated Chewing Gum:
Development of medicated chewing gum thru Tableted gum technology
*Include drug devicedevelopment support, device design, selection, development and optimization.
Problem Solving:
Resolving analytical method challenges with innovative solutions for fine tuning to upgrade methods as per current guidelines as well for regulatory submission and deficiency response
Particle size Analysis (size and morphology):
Precision-driven insights into particle characteristics for optimized formulation and performance.
Analytical Development
Delivering comprehensive analytical solutions tailored to your needs.
Reverse Engineering:
Qualitative and Quantitative determination of individual components in reference formulation to determine concentration and/or form ducts.
Drug Substance and RLD Characterization:
Characterization of Drug Substance to find sameness with individualized characterization study to compare with RLD. RLD characterization with respect to design space for Drug Product Development.
Method Development & Validation:
Customizable analytical method development and validation tailored through Design of Experiments (DOE) and Quality by Design (QbD) processes that meet all compendial and regulatory requirements. as per specific requirements.
In Vitro Bioequivalence:
Strategy Establishment, Method Development and Comparative Testing to either augment or substitute clinical strategies through comparison of Reference Standard (RS) verses Test Product for In Vitro Bioequivalence (IVBE) studies as well as In Vitro Release Test (IVRT).
Stability Program Management:
Design and analysis of stability programs ensuring product integrity over time for shelf life determination.
Pharmacopeial Testing:
Rigorous testing and verification according to pharmacopeial standards.
Stability Indicating Methods:
Expert development of stability indicating methods for complex drug products.
Clinical Operation
Tailored solutions for all your Clinical Strategy, Design, Operations, and Compliance needs.
Clinical Strategy and Design:
Our Strategic Product Development & Consulting service encompasses a forward-thinking approach to drive innovation in drug development, leveraging in-depth expertise and strategic insights to propel products successfully through their lifecycle. Developing target product profiles, drafting Clinical Development Strategy & Plans, designing study synopses and trial protocols, Benchmarking clinical trials, Strategizing disease indication and lifecycle management with drafting regulatory correspondence and interactive support.
Biostatistics and Data Management:
With expertise in cutting-edge technologies and stringent regulatory compliance, we manage precise, accessible, and reproducible high-quality Biostatistics and data management which covers creating Statistical Analysis Plan (SAP), Statistical Analysis & Reporting (SAR), Sample size estimation & Power Calculation, Scientific inputs to the study conclusion & Report preparation.
Clinical Operations Support:
Our robust CRO, investigator, sites, KOL network and expertise in clinical operation make us well-positioned to address the challenges in executing the clinical studies. We offer a solid foundation and a comprehensive array of services to navigate the complexities of single as well as multi-centric clinical programs across various therapeutic areas. Our services encompass the entire clinical operation stages, from initial study feasibility till delivery of final results.
Quality Assurance and Compliance:
Our steadfast commitment to excellence drives our approach to Quality Assurance (QA). With emphasize on delivering transformative clinical research demands nothing less than best-in-class QA, ensuring compliance and supporting clinical trials that lead to market approvals, ultimately enhancing lives.
Module 5 Technical writing:
PK Reports, CSR Appendices, CSR body (full, abbreviated, synoptic) for Phase 0, I-IV studies Writing of product information, any PK data summary, clinical data summary, reference safety information
Regulatory Affairs
We offer a proactive and expert approach to regulatory affairs, empowering pharmaceutical companies to navigate complexities with confidence, compliance, and efficiency.
Regulatory Strategy:
Our seasoned professionals collaborate closely with your team to develop comprehensive strategies, tailored to your products and target markets. Proactively navigating regulatory complexities, we streamline approvals and minimize time to market.
Submission Management:
From INDs to NDAs/ANDAs, our experienced team handles all regulatory submissions with precision, ensuring accuracy, completeness, and compliance. We facilitate smooth processes from compilation to electronic submission.
Labelling Compliance:
Navigating local and international regulations, including FDA requirements, our experts ensure product labelling and packaging materials meet regulatory standards for safety and efficacy, ensuring market readiness.
US Agent Services:
For ex-US pharmaceutical companies entering the US market, we provide comprehensive US agent services. Acting as a single point of contact between FDA and applicants, we facilitate submission processes and ensure seamless control over correspondences.
R&D Quality Assurance
Trust our expertise to safeguard the integrity, compliance, and safety of your innovations with a touch of quality.
Regulatory Audit Support:
Comprehensive audit services for CROs, CMOs, and CTLs to ensure regulatory compliance.
Facility & System Audits:
In-depth gap analysis and audits to meet cGMP, GCP, GLP (GxP), and other regulatory standards.
Vendor-Independent Audits:
Objective qualification and audits for APIs, excipients, devices, and specific projects.
Lifecycle Quality Implementation:
Complete quality management throughout the entire product lifecycle for continuous compliance.
Intellectual Property Rights
Transforming ideas into valuable assets with expert IP strategy and support.
Patent Landscape Analysis:
Assessing the competitive IP environment to guide in-house development strategy.
Patentability Assessment:
Evaluating the potential for patent protection of your innovations.
Freedom to Operate Analysis:
Ensuring your product can be developedwith professional IP clearance on existing patents.
PIV Litigation:
Providing non-infringement and invalidity opinions to support patent infringement disputes.
PIV Certification:
Preparing for patent infringement and validity certifications.
IP Due Diligence:
Conducting thorough assessments to support investment and acquisition decisions.
Patent Filing and Prosecution:
Managing the filing process and prosecution of patents to protect your innovations.
Customized Project Management Support
Streamlining project success with tailored project management approach, transparent tracking, and proactive solutions.
Communication & Governance:
Establishing robust structures tailored to your project’s needs.
Resource Allocation:
Ensuring efficient use and continuous monitoring.
Risk Management:
Conducting assessments and proactive mitigation strategies.
Tracking & Accountability:
Transparent monitoring of milestones, budgets, and timelines.
Change Management:
Minimizing disruptions with strategic approaches.
Stakeholder Communication:
Ensuring alignment and satisfaction throughout the project lifecycle.
Portfolio Selection and Commercial Assessment
Guiding your journey with expert insights and innovative strategies
Portfolio Selection Services:
Years of experience drive the portfolio management action that increases the value and marketability of any given product. Having a clear roadmap into the future for any product increases the value of the assets. Services can be provided that expands the outlook of any product in the following areas:
Product Positioning:
Where a product fits in a comprehensive manufacturing and marketing portfolio
Life Cycle Management:
Establishment of a clear therapeutic picture of the competitive landscape, product potential, and potential alternatives to extend the profitability of selected indications and/or molecules
Complementary Product Options:
Evaluation and recommendation of additional product offerings that will complement sales offerings.
Commercial Assessment:
Commercial Assessment services empower pharmaceutical companies to make data-driven decisions, ensuring the selection of high-potential products that align with market needs and strategic goals. Providing comprehensive consulting expertise for market trends, competitive landscape, and patient needs to identify and prioritize opportunities with the highest commercial value. Our approach integrates robust market analytics, financial modeling, and risk assessment to forecast product performance and profitability.
Therapeutic Knowledge:
Leveraging deep area knowledge to craft effective development roadmaps.
Strategic Advice:
Steering compounds towards filing and commercialization with a focus on profitability.
Dosage Optimization:
Assisting with adjusting dosage administration, repurposing molecules, and refining dosage forms.
Licensing Support:
Helping with in-licensing/out-licensing portfolios and platform technologies.
Innovative Navigation for 505 (b):
Guiding your journey towards success with precision and innovation.