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healthcareWelcome to FWQRC……health-304919__340

About Us:

FWQRC is the service organisation based at Hyderabad,working for the benefit of the entire life science sector. It is driven by a group of pharmaceutical experts. Its main objective is to improve and maintain industry standards which will support prosperous growth and business development for the life sciences industries (Pharmaceuticals / Biotech / Food  / Chemical / Herbal / Medical devices) and Healthcare Institutions.

The mission of “FWQRC” (Fire Water Quality & Regulatory Compliance) is to provide our clients the highest quality of Regulatory Affairs, Quality Assurance and Quality Control services allowing them:

  • Operate continuously in compliance with local and global regulatory requirements and quality standards.
  • Bring their products to market faster.
  • Extend their business globally with minimum risk and reduced cost.
  • Focus on their core business while we are handling all their regulatory and quality needs.

WHO WE ARE:

We are business to business service providers. FWQRC provides a full spectrum of tailored Regulatory Affairs, Quality Assurance and Quality Control Services to start-ups, small and mid-size pharmaceutical and medical device companies worldwide.

Our main focus is to provide our life science clients with tailored services that meet their business needs, fit their budget and support their strategic growth globally.

Our team of professionals has decades of experience in Regulatory Affairs, Quality Assurance and Quality Control, and has helped many life science companies register their products successfully and efficiently in US, Latin America, Europe, Brazil and Asia.

We are committed to providing high quality services to our customers to achieve a high level of customer satisfaction at all times.

Faculty Members:

Duraimurugan Anbalagn, Chief Executive officer

Certified pharmaceutical GMP Auditor / Certified Lean Six Sigma Black Belt

Proven Quality & Regulatory leader with 18 years’ experience in the drug substance and drug product pharmaceutical industries. Expertise including, but not limited to the following; creation,implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR,Part 210,211,ICH and ISO 9001-2015. Manage all aspects of regulatory compliance. Correspond with FDA and EU notified bodies. Prepare and maintain international product registrations. Filling facility registration and Product Listings. Maintenance of regulatory files, consistent with state, federal and international regulatory requirements.Provide knowledge and support to the company to enable company to operate within regulatory guidelines.

Core competencies 

  • Develop regulatory strategies for U.S, Europe, Chinese, Brazil, and Mexican markets.
  • Host FDA and regulatory agencies audits.
  • Complete annual registrations.
  • Review and interpret regulatory rules as they relate to company products and processes.
  • Conduct ongoing company-wide training on FDA,EDQM and ISO requirements.
  • Assess need for regulatory registrations and act accordingly.
  • Document Control process and the efficient control of all documentation required by regulatory agencies.
  • Define needed quality metrics and coordinate data collection from various functions.
  • Perform Quality Management Reviews and advise management of any product or process related issues and make recommendations for improvements.
  • Administer and manage supplier qualification activities and monitor suppliers’ performance.

Muthamizhselvi, Director, Business Development

Muthamizhselvi, has a unique combination of expertise in preparation of drug master file (DMF) electronically and business development processes allowing her to understand the regulatory needs of life science companies and consequently providing them with the appropriate solutions to satisfy those needs in coordination with technical experts in the FWQRC.

Other Team Members

Other team members are experienced in Regulatory affairs, Quality management systems, Compliance, and Auditing.

The team is expertise in submissions for pharmaceutical drug substances, drug products, multiple medical devices and managed different compliance activities to ISO standards, FDA, and European regulations among other international market authorizations of products.

Technical team is Certified Lead Auditor for GMP issued by INTERNATIONAL SOCIETY FOR QUALITY AND SAFETY IN HEALTHCARE.

Other Team members has exposure working with national & international regulatory standards such as new EU Regulation , Good Manufacturing Practices (GMPs), ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 211, RDC 185 (ANVISA in Brazil), and Latin America regulations among others.

Policy of FWQRC 

  • We are committed to providing high quality services to our customers to achieve a high level of customer satisfaction at all times. 
  • We are aware that consistent satisfaction of our customers is vital to our business development and expansion. So, we persistently work towards securing a long term partnership with each customer and intend to do so through the following:
  • Emphasis human values and personal relations, so we put a great effort on proper communication, transparency and human relation which form an integral part of  culture.

Why Choose FWQRC

Our clients view their relationship with FWQRC as a partnership. When you are successful, we are successful.

Your product has the potential to improve life for millions around the world. To reach its fullest potential, each product must meet various complex and rigorous regulatory standards. FWQRC is a dependable business ally with domestic and international regulatory expertise.

Whether your organisation needs a customised strategy or a standardized approach, we take pride in accurately assessing your regulatory needs and then providing the appropriate support, services, and unique solutions necessary to produce successful outcomes for your organisation.

Benefits of Working with FWQRC

  • Team members of FWQRC work with the same level of passion as that of our clients. We help them overcome regulatory hurdles and get their products to market as quickly as possible.
  • We handle all your regulatory and quality needs so that you can focus on the science and technologies and business developments activities.

With FWQRC, You:

  • Have a peace of mind
  • Have no risk of regulatory non-compliance
  • Get shorter time to market
  • Avoid unnecessary costs and delays

Expertise

With Our expertise lies in strengthening medical device, pharmaceutical and biologic organizations from their products’ concept through regulatory approval. We have a team of experts rather than generalists, focusing our strengths to do a highly effective job for a very specific group of clients.

Tailored Services

Regulatory Affairs:

  • Dossier preparations (eCTD)
  • Filing of USDMF, European DMF, MHRA, HPRA
  • Addressing the DMF deficiencies
  • Risk assessment for Elemental Impurities
  • Risk assessment for Genotoxic Impurities

Quality Assurance:

  • GAP analysis / Risk Assessment / CAPA
  • Conducting third party vendor audit
  • Preparation of responses to the audit observations
  • Implementation of Standard operating procedures in line with current guidelines
  • Imparting GMP training 
  • Root cause analysis for the deviations, OOS and Customer complaints

Quality Control:

  • Analytical method development
  • Analytical method validation
  • Analyst Qualification
  • Establishing ADE / PDE Values during the equipment cleaning process

The main goal of FWQRC is to provide tailored services that meet your needs and help you overcome your specific challenges for better outcomes.

Flexibility

FWQRC offer flexible services. You can use FWQRC team as needed with no long term commitment. This allows you a better control of your operating costs and meet your business goals in a timely manner while using FWQRC team of professionals.

Efficiency

We always offer you the best options to meet your goals in a timely manner while staying in your budget. We are competitive, honest and realistic. Regulatory compliance is a big job. Even if you know what you need to do, sometimes you simply don’t have enough people to get it all done. When you need extra hands, think of us as your virtual regulatory compliance team. Give some or all of your work to us and we’ll get it done.

Extra Effort and Care

Whether you are a large multinational or an early stage life science company, FWQRC always provide you the same level of quality and personal service. We take pride in our accountability to our clients and have a large base of repeat and long-term customers. Our senior leadership is deeply involved in day-to-day activities to ensure that our clients receive excellent and tailored services that meet their needs.

Because FWQRC care about your success, FWQRC not only a service provider but we consider ourselves your partner who makes sure that you are and stay on the right path at the right time during the whole life cycle of your products.

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