Elevate Your Drug Substance Development and Manufacturing Efficiency with Proven Expertise
At M K Consultancy, we support the US, UK, Europe pharma industries to introduce and develop the drug substance manufacturing technology in Indian CRO, CMOs. We are specialized in delivering comprehensive solutions for Drug Substance Development across the spectrum of key areas, ensuring your project thrives, processes are optimized, and quality standards exceeds the global regulatory requirements. With a focus on precision, innovation, and strategic planning, we bring a wealth of experience to every project.
M2K Represents "Manufacturing, Management and Kuality"
About M K Consultancy
Established by Dr. Manoj Kakwani, a certified PMP® leader, a dynamic freelancer with over 15 years of experience and specialization in API Process Research & Development (PRD), CMC Operations, Technology Transfer, Strategic Planning, and Process Validation. Dr. Manoj & Team brings unparalleled expertise in crafting phase-appropriate chemistry and directing synthetic process of pre-clinical candidates to the Commercial APIs.
At M K Consultancy, we offer comprehensive solutions for drug substance development and manufacturing. We go beyond by offering support for conducting pre-validation studies, ensuring a solid foundation for successful process validation, and facilitating the demonstration of a validated and effective process. Our services are designed to guide you through each crucial step, ensuring not only compliance but also the efficiency and success of your validation processes.
Additionally, we specialize in crafting quality and regulatory documents to support NDA (New Drug Application), IMPD (Investigational Medicinal Product Dossier), and other essential submissions. Committed to cultivating synergy between Indian CROs/CMOs and the rigorous quality / compliance standards mandated by the US FDA, EU, and other global regulators.
Our Services
Partner Building
"Partner Identification and building" in M K Consultancy refers to the strategic process of establishing and nurturing relationships
Project Planning, Execution & Timely Delivery
Successful project management involves a continuous interplay between planning and execution, all with the goal of delivering
Robust, Cost-Effective and Quality Process Development
We support in crafting phase appropriate process for drug substance manufacturing, which is not only robust but also cost-effective.
Research Experimentation and Data Analysis
From experimental design to accurate data analysis, we employ a data-driven approach. Our dedication to study documentation
Technical Support for Manufacturing Operations
Technical support for manufacturing operations is critical for ensuring the efficiency, reliability, and compliance of production processes.
Process Validation and Documentation as per cGMP
"Process Validation and Documentation as per cGMP" involves systematically establishing evidence that a process consistently produces a product meeting
Our Services
Committed to strengthening the harmonization between Indian manufacturers and the rigorous quality and compliance benchmarks established by the US FDA, our bio-pharma consultancy based in India centers its efforts on closing the cultural divide. Our experienced India specialist boasts a wealth of more than 15 years, marked by extensive residence and work within India during a transformative era
Partner Building
"Partner Identification and building" in M K Consultancy refers to the strategic process of establishing and nurturing relationships between Indian Chemical Industries / Pharma Industries / CROs / CMOs with Global Pharma Giants. It involves identifying, creating, and sustaining partnerships that contribute to shared goals, growth, and success. We achieve this by Strategic Alignment, Relationship Development, Trust and Transparency, Adaptability, Communication Channels, Conflict Resolution, Long-Term Vision, KPIs Measurement / Evaluation.
Project Planning, Execution & Timely Delivery
Successful project management involves a continuous interplay between planning and execution, all with the goal of delivering a quality product or service on time. It requires a keen understanding of the project's scope, careful resource management, effective communication, and the ability to adapt to unforeseen challenges. Our meticulous approach to project management guarantees not only the setting of clear objectives but the timely delivery of milestones. We navigate risks, adhere to timelines, and keep all stakeholders informed throughout the project lifecycle.
Robust, Cost-Effective and Quality Process Development
We support in crafting phase appropriate process for drug substance manufacturing, which is not only robust but also cost-effective. Our commitment to continuous improvement ensures operations stay at the forefront of efficiency. Quality Process Development is an integral part of our services and commitment to delivering products or services that meet or exceed customer expectations while complying with regulatory requirements. It involves a dynamic and iterative approach to continually enhance processes and maintain a high level of quality throughout the product or service lifecycle.
Research Experimentation and Data Analysis
From experimental design to accurate data analysis, we employ a data-driven approach. Our dedication to study documentation ensures transparency and replicability in every experiment. Process Mapping and Analysis, Technology Integration, Quality by Design (QbD), Risk Assessment, Process Verification and Validation are key elements for research experimentation and data analysis.
Technical Support for Manufacturing Operations
Technical support for manufacturing operations is critical for ensuring the efficiency, reliability, and compliance of production processes. It requires a combination of technical expertise, effective communication, and a proactive approach to problem-solving to keep manufacturing operations running smoothly. At M K Consultancy we provide Remotely / Onsite seamless technical support, effective troubleshoot, facilitate cross-functional collaboration, and ensure a smooth technology transfer from development to manufacturing.
Process Validation and Documentation as per cGMP
"Process Validation and Documentation as per cGMP" involves systematically establishing evidence that a process consistently produces a product meeting pre-determined specifications and quality attributes in accordance with Current Good Manufacturing Practices (cGMP). Our expertise will help in achieving the process validation goal by Process Design, Pre-Validation Studies like RSM Justification, Control Strategy, JOS, Process Characterisation Studies, Process Performance Qualification (PPQ), Validation Master Plan (VMP), Regulatory Reporting, Audit Readiness. We ensure all processes are not only optimized for efficiency but also adhere to the stringent standards of Current Good Manufacturing Practices (cGMP). Our commitment to documentation and audit readiness sets us apart.
Spotlights
PROCESS RESEARCH AND DEVELOPMENT – A CASE STUDY
API DEVELOPMENT FROM EARLY PHASE TO COMMERCIALISATION
EMBARKING ON A JOURNEY: SUCCESSFUL PRE -VALIDATION TO VALIDATION EXCELLENCE
COST CUTTING DEVELOPMENT FOR COMPETITIVE MARKET
Our Team
We are specialized in providing holistic solutions across a diverse range of critical areas, guaranteeing the success of your projects, the optimization of processes, and the surpassing of quality standards. Anchored in precision, innovation, and strategic planning, we bring a wealth of experience to each project, ensuring excellence in every endeavour.
Dr. MANOJ KAKWANI
Founder M K Consultancy
Manoj, a highly qualified pharmaceutical professional with a Ph.D. and Masters in Pharmaceutical Chemistry, brings over 15 years of expertise in various capacities within the industry. His roles in leading companies like Syngene International Ltd, Aarti Industries Ltd, and Rusan Pharma Ltd involved managing drug development and manufacturing processes, including R&D, analytical development, project management, quality assurance, and regulatory submissions.
Transitioning to freelancing, Manoj founded M K Consultancy, where he serves as a Drug Substance Development and Manufacturing Consultant. Operating globally, he collaborates with clients in the US, UK, and Europe, overseeing diverse areas such as process development, project management, operations, quality assurance, supply chain management, Process Validation, and strategic planning. Notably, he holds a Project Management Professional (PMP)® Certification from the Project Management Institute (PMI), showcasing his proficiency in project management methodologies. Manoj's comprehensive skill set, academic background, and industry experience position him as a valuable consultant in the pharmaceutical field.
Teams Information – Coming soon.
Grow Your Business with Confidence
Get in touch today to discuss your next project and we will happy to answer any questions and provide you with a no-obligation FREE Consultation.
Let's Discuss Your Project
To help us get an idea of what you need, please fill in this contact form and we’ll get right back to you.
-
cmc.mkconsultancy@gmail.com
manoj.kakwani@gmail.com -
Smondoville, Electronic City Phase I Bengaluru
Palava City, Thane, Mumbai. -
+91 9892636964
+91 9321460700 - www.m2kconsultancy.com