Arvkta

  • www.arvkta.com
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INDIA

UAE

QATAR

NEPAL

Consulting Services

Outsourcing and Consulting for Analytical, Compliance and Regulatory Services

Arvkta is an outsourcing and consulting company providing expertise in pharmaceutical development and compliance activities, from initial product development through to compilation and support of regulatory submissions. Based in India, the company’s principal officers have extensive practical industry experience. Arvkta is built on the premise that the execution and management of analytical, compliance and regulatory activities for pharma business are extremely complex fields that require extensive training and experience to ensure that these activities are effective and acceptable to the relevant health authorities. Some of these activities are not inherently a do-it-yourself prospect, and they can benefit enormously from the knowledge and experience of professionals who are subject matter experts. Business people who want to ensure that their activities meet the requirements of regulatory bodies need to find quality vendors of reliable service and support. These vendors should be viewed as a trusted partner, helping them take their business to the next level of success. Arvkta is such a vendor. It serves its clients with the loyalty of a business partner and the economics of an outside vendor. We make sure that our clients have what they need to run their businesses as well as possible, with maximum efficiency and reliability.

Consulting services

Sometimes it is necessary to obtain advice from experienced practitioners in order to meet the regulatory requirements in the pharmaceutical industry. Arvkta’s experienced consultants can help guide you in the right direction and partner with you to achieve the desired outcome. Some examples of where we could assist are:

  • Laboratory Health and Safety Systems
  • Solvent and/or Chemical Management/Segregation
  • Audit advice
  • Pharmaceutical Development
  • Calibration program design
  • Analytical Method Validation
  • Process Validation
  • Equipment Validation
  • System Validation

Outsourcing services

Arvkta’s outsourcing solutions means your lean workforce can continue to add value by performing their core competencies while the non-routine work is handled by competent professionals. Some examples of outsourcing solutions are:

  • Hazardous Substances Risk Assessments
  • Laboratory Documentation System
  • Internal Audit Programs
  • Equipment Validation
  • Pre-Inspection Audits
  • Management of Calibration Program
  • Validation Protocols and Reports
  • System Validation Packages
  • Master Document Design
  • Regulatory Dossier collation

Analytical services

Arvkta has been founded by directors who have extensive experience in managing a large MHRA TGA and FDA approved laboratory. The combined knowledge of our consultants ensures that all analytical areas are covered; from working as a chemist on the bench through to operating a large, busy laboratory, we have the knowledge and expertise to help you. Our consultants can aid you in functions required to run any laboratory (such as validation, calibration, audits), to more specific functions such as how to set up your documentation systems. We understand the whole process involved in the pharmaceutical industry, from formulation through to distribution, and therefore appreciate where an analytical laboratory fits in, and the importance of providing quality data with impeccable documentation. We pride ourselves on never compromising on quality, while always searching for ways of increasing productivity. The services we offer include (but are not limited to):

  • Laboratory Operations
  • Analytical Equipment Validation
  • Analytical Equipment Calibration
  • Analytical Method Validation
  • Process Validation
  • Stability Studies
  • Analytical Documentation for Dossier Preparation

Laboratory Operations

Our consultants have comprehensive experience managing a large pharmaceutical laboratory that has successfully passed all audits from health authorities across the world (e.g.MHRA, TGA, FDA). They can advise you on ways to increase your efficiency and decrease your costs while still remaining focussed on quality, the foundation of the pharmaceutical industry. Some areas that we can offer services in or consultation for include (but are not limited to):

  • Laboratory Health and Safety systems
  • Hazardous Substances management, including risk assessments
  • Solvent and Chemical management/segregation
  • Advice on new laboratories, both greenfield sites and incorporation into existing buildings
  • Workflow design, to ensure the most efficient use is made of existing resources
  • Good Laboratory Practice
  • Laboratory documentation systems

Analytical Equipment Validation

There is an increasing focus on ensuring all analytical equipment is validated to comply with a range of industry guidelines, including PIC/S, GAMP and 21 CFR Part 11. This can be a daunting task if you are not familiar with the requirements and have little experience in what is acceptable. Our consultants have up to date knowledge of all analytical equipment validation requirements for the pharmaceutical industry. They can advise you on all testing needs and methodologies. Some of the services we can offer are:

  • Design of equipment validation studies
  • Design and preparation of validation protocols
  • Design and preparation of final validation reports
  • Review of IQ/OQ procedures from vendors for compliance with PIC/s, GAMP and 21 CFR Part 11
  • Alternatively, we are able to perform the validation for you and provide you with a complete set of supporting documents upon completion

Analytical Equipment Calibration

In any laboratory there is a requirement to ensure all equipment used is functioning correctly for its intended purpose, both when new and on an ongoing basis. Our consultants have designed and implemented extensive calibration programs for all equipment used in a typical pharmaceutical laboratory. We can offer you:

  • Advice on which equipment should be calibrated, how often, by who
  • Design of a comprehensive calibration program to suit your needs
  • Management of the calibration program on your behalf

Analytical Method Validation

Method Validation is an extremely important part of any drug substance or drug product testing program. Through the method validation process, documented evidence is obtained that shows that each method is valid for its intended purpose. Our consultants have experience in all aspects of analytical method validation, and can advise and design studies with you.

  • Design/write method validation protocols
  • Design/write method validation reports

We are also able to take the data you have generated and compile a thorough and professional report, ready for submission to any health authority.

Process Validation

Process Validation encompasses Manufacturing Validation and Cleaning Validation studies. Few companies have the luxury of having dedicated suites for each product they manufacture, so cleaning validation studies are a must-have of the industry. Manufacturing Validation studies are required for new product submissions as well as on commercial scaleup or when changes are made to existing formulations. We can:

  • Design/write cleaning validation protocols and reports
  • Advise on methodologies for cleaning validation testing, best swabbing method, swab extraction efficiency studies
  • Design/write manufacturing validation protocols and reports

Stability Studies

Process Validation encompasses Manufacturing Validation and Cleaning Validation studies. Few companies have the luxury of having dedicated suites for each product they manufacture, so cleaning validation studies are a must-have of the industry. Manufacturing Validation studies are required for new product submissions as well as on commercial scaleup or when changes are made to existing formulations. We can:

  • Design/write cleaning validation protocols and reports
  • Advise on methodologies for cleaning validation testing, best swabbing method, swab extraction efficiency studies
  • Design/write manufacturing validation protocols and reports

Analytical Documentation for Dossier Preparation

Laboratory results and data are a large part of any submission to a health authority. They are the basis for showing the product quality and how this will continue to be monitored once the product has market approval. Our consultants have extensive experience in designing and implementing quality documentation that is clear, concise and accepted across the world. We can offer you:

  • Advice on how to present your data
  • Services whereby we take your data and provide you the final reports/documents ready for submission
  • Advice on exactly what is required for each health authority
  • Testing requirements for both drug substance and drug product, for the global market

If you have any analytical issues that you need assistance with, whether it is listed above or not, contact us and we will show you how we can help!

Compliance Services

Compliance is at the forefront of pharmaceutical companies’ minds today. It can be defined as the set of activities that companies must undertake to meet all regulatory requirements. Without an adequate compliance program, companies can face the threat of fines and more scrutiny from regulatory bodies. Compliance activities can be complex and time consuming, and guidance’s can be inherently risky to interpret without a degree of assistance from experienced practitioners. Tightening of the governance of areas such as electronic records and signatures, equipment installation and operation, and the validity of test results means that there are frequent changes to the steps required to ensure that audit and filing deficiencies are kept to a minimum. Our consultants have broad exposure with requirements to meet the expectations of regulatory bodies both in MHRA,GCC,FDA and MCC markets. Our compliance services include (but are not limited to):

  • Master Documents Design
  • Compliance Systems
  • System Validation Services

Master Documents Design

Our consultants have in-depth experience in the implementation and maintenance of documentation systems. They are able to generate documents from the product development stages through to full commercial (QA) systems. Some examples of the documentation that can be designed and/or provided by our consultants are:

  • Standard Operating Procedures
  • Analytical testing procedures
  • Method Validation protocols and reports
  • Manufacturing Validation protocols and reports
  • Cleaning Validation protocols and reports
  • Stability Protocols.

Compliance Systems

Our consultants have extensive and up-to-date experience with regulations covering a broad range of systems and activities. They are able to advise on the best way forward, or alternatively, can manage the activities for you. Our compliance services include:

  • Consultation for developing a compliance documentation framework
  • Analytical equipment selection (including generation of URS), purchase and commissioning
  • Analytical equipment validation and calibration design, protocols, reports and execution
  • PIC/S, GAMP and 21 CFR Part 11 compliance evaluation, strategy planning and execution
  • Laboratory Occupational Health and Safety systems
  • Design and plan analytical development strategy

System Validation Services

Any new software application requires appropriate validation to ensure it is in compliance with all relevant standards. Our consultants have hands-on experience in designing appropriate validation protocols, testing regimes and final reports for small and large applications. From your HPLC software system to large electronic document management systems, we can help you fulfil your regulatory requirements. Our services in this area include:

  • Writing validation protocols
  • Designing User Acceptance Testing protocols
  • Writing validation reports

If you would like to discuss your needs with us and see how we can help you, contact us!

Regulatory Services

PharmAssure can provide Regulatory Affairs Consultants with extensive and up-to-date knowledge of registration requirements for generic pharmaceutical products in Australia, Europe, New Zealand, USA and Canada.

Our experience covers all areas from planning submissions, compilations of dossiers and response to questions. We are able to provide either consultation or outsourcing solutions for all your registration needs, including the upcoming requirements for eCTD filings.

Our regulatory services include (but are not limited to):

  • Dossier Compilation
  • Dossier Review
  • Training

Dossier Compilation

Our consultants are able to prepare a dossier on your behalf, for any of the major markets (USA, Canada, Australia, GCC,New Zealand or Europe). They will support you from the initial submission, through any deficiency responses and up to product approval.

Dossier Review

Our consultants are able to review your registration strategy and advise you on the data requirements for all major markets. They can review your final application and advise on any alterations/additions that may be required to ensure acceptance.

Training

Our consultants have extensive experience across the world, and are therefore well placed to provide training in all areas of regulatory affairs.

Dossier Review

Our consultants are able to review your registration strategy and advise you on the data requirements for all major markets. They can review your final application and advise on any alterations/additions that may be required to ensure acceptance.

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Our Offerings

Recruitment Process Outsourcing (RPO)

Our Recruitment Process Outsourcing offering sources and attracts talent through our flexible and scalable recruitment solutions which can include anything from sourcing and selection to onboarding. Built upon our deep recruiting expertise and based on our rigorous process, our innovative approach ensures the results you need greater predictability of cost, a more efficient recruiting process, an improved candidate experience, and more importantly, improved talent quality.

Managed Service Provider (MSP)

TAPFIN, our Managed Service Provider, delivers solutions that optimize the management of contingent workforces, providing visibility, predictability, and the performance you count on. Our quality program management, efficient process, breadth of services and global reach make us the largest and most respected hybrid and vendor neutral MSP in the world.

Strategic Workforce Consulting

Strategic Workforce Consulting is an industry-leading framework and collaborative planning process that creates a workforce strategy aligned to your business strategy. We leverage our in-depth understanding of global workforce trends and our workforce solutions expertise to deliver a strategy with a measurable action plan to accelerate the execution of your business strategy.

Talent Based Outsourcing

We provide talent-driven outsourcing of operations, functions and services to drive the productivity you need to succeed in a more demanding world. Our capabilities range from contact centers to manufacturing functions to IT help desks and any place in between. We leverage over 60 years of experience and our unmatched expertise in sourcing and managing talent to recruit, execute and deliver the results you need to win.

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