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 Consultancy) 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.
Core competencies :
- Develop regulatory strategies for U.S, Europe, China, Brazil, and Mexican and ROW 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.
Mr.Duraimurugan Anbalagan, M.Sc., M.Phil, Ph.D (Pursuing), Biotechnology, Founder of FWQRC
Proven, Quality & Regulatory leader with two decades of experience in the pharmaceutical and related industries. IRCA Certificated Lead Auditor (QMS), ISO Certified Lead Auditor (IMS), ISQSH Certified Pharmaceutical GMP Auditor and Certified Lean Six Sigma Black Belt. Currently handling as Freelancer (providing GMP Training, Conducting First & Second party audits and GAP analysis/Risk Assessments for the health care industries and institutions
Expertise including, but not limited to the following; creation, implementation and maintenance of the Quality System processes, in compliance with FDA 21 CFR, Part 210,211,EUGMP, ICH, WHO and ISO 9001-2015. Safety system process in compliance with CFR 29, 40, and 49 and all applicable safety, health, and environmental regulations including OSHA, EPA, and state / local regulations. Manage all aspects of regulatory compliance. Correspond with FDA and EU notified bodies, Pollution control board
Prepare and maintain international product registrations. Filling facility registration and Product Listings. Maintenance of regulatory files, consistent with state, federal and international regulatory requirements. Support pharmaceutical industries on performance measures for quality and safety improvements and compliance. Provide knowledge and support to the company to enable company to operate within regulatory and safety guidelines
Mrs.Muthamizhselvi, M.Sc, Information Technology, Managing Director of FWQRC
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.
Dr.Govindan Solai, Ph.D, Chief Technical Services (Operations)
A result-oriented professional scientist with 35 years of experience in Basic research, bench scale development, Technology Transfer, Process Development, Manufacturing Operations and Technical Services of API, Pharmaceuticals, Chemicals and Herbal Products . Possess in-depth knowledge of Technology Transfer, Process Engineering, Multi Product Manufacturing and New Product Development. Adroit in process assessment with respect to Chemistry, Safety and Operations. Gained exposure in process Validation and Safety Evaluation System
Mr.K.R.Elumalai, M.Sc., Chemistry, Ph.D (Pursuing), Chief Technical Officer (Quality System)
Proven Quality Professional with 30 years of extensive experience across operations related to Quality Functions in API, Solid, Semi-Solid and Oral Liquid formulations, Process as well as Analytical R&D
Expertise in applying quality management tools/approaches to reporting processes within the business unit; skills in formulating & maintaining research objectives complementary to corporate policies/ customer demands
Strong exposure in assuring that all developed products/processes have represented the maximum quality & reliability attainable by establishing effective quality inspections
Proficient in compilation of data to prepare reports through detailed result analysis & inferences
An effective communicator with excellent relationship management skills and strong analytical, problem-solving capabilities
Well versed with relevant ICH, 21CFR, WHO, GXP, ISO, CSV GAMP, PIC/S and EU regulatory requirements for GMP and GCP
Ms.K.V.S.Susmitha, M.Pharm in Regulatory Affairs, Specialist Regulatory Affairs (Food, Drugs & Cosmetics)
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.Certified Pharmaceutical GMP Auditor issued by INTERNATIONAL SOCIETY FOR QUALITY AND SAFETY IN HEALTHCARE.
Core Competencies: Expertise in Global eCTD publishing & Submission services, Nees submissions, Paper Submissions, Structured product labeling (SPL), Regulated product submission (RPS), Drug Master File (DMF) submissions, NDC Labeler code, FEI registrations, etc
Mr.D.Vasanthakumar, M.Sc, Specialist Computer System Validation
Expertise in computer system validation ( GAMP V). Expertise in national & international regulatory standards such as new EU Regulation , Good Manufacturing Practices (GMPs), ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 11, and other regulations.
Mrs.Roopa, BE, Biomedical, Specialist Regulatory Affairs (Medical Devices)
An enthusiastic person with highly motivated and leadership skills having bachelors of engineering degree in Biomedical Engineering with total 6 years of experience in Regulatory Affairs & Medical coding
Core Competencies: Expertise in submissions for multiple medical devices and managed different compliance activities to (EU) MDR 2017/745 and IVDR, USFDA 510(K), 513 (g), 501(k), MDUFMA, and ISO standards among other international market authorizations of products
Expert in implementation of each step of project. Eager to learn new technologies and methodologies. Always willing to innovate the new things which can improve the existing technology
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
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.