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Trinetra – The Third Eye


Your Third Eye to Compliance


To perceive something beyond the visibility of the normal pair of eyes, which is possible only by the third eye. Any companies that are seeking quality and regulatory compliance needs a third eye view to find out what are the critical and significant elements that are missing to attain 100% Compliance according to the applicable Standards and Regulations. Trinetra Solutions functions as your third eye.

Your Third Eye to Compliance To perceive something beyond the visibility of the normal pair of eyes, which is possible only by the third eye. Any companies that are seeking quality and regulatory compliance needs a third eye view to find out what are the critical and significant elements that are missing to attain 100% Compliance according to the applicable Standards and Regulations. Trinetra Solutions functions as your third eye.

Supergood Eye for Detail One of the basic qualities of the Quality and Regulatory Affairs Professionals, is to have a sharp/keen eye for detail. Remarkable attention for details is an important asset of Trinetra Solutions.









Wholeness of the Scenario Trinetra Solutions functions as an eagle eye to give an overall/ bigger picture about the Quality and Regulatory Compliance without loosing the details.











Neutral & Impartial Being in a neutral position to give an idea of what is needed precisely according to the EC Regulations and Legislations by the Local Competent Authorities and how it could be fulfilled economically and, in a time, efficient manner.







About Us



OUR SERVICE is extended to the pharmaceutical industry and academic research institutions to achieve quality assurance and regulatory compliance in your field of pharmaceutical, medical device, IVD, biological, dietary and dietary supplements, cosmetics and other relevant healthcare products.

OUR VALUE is to perceive the requirements based on an individual thriving company's need, simplify the process and enable your company 100% compliance to ensure safe healthcare.






OUR GOAL is to offer solutions to meet your timeline at every checkpoint thereby to excel your business in the world market.










OUR STRENGTH is our abreast knowledge and experience about the international Quality and Regulatory requirements



OUR UNIQUENESS The moment of our commitment to your project transfers your responsibility to our shoulder and your success becomes inevitable.

OUR PROMISE is to you, Perceive and deliver the need and beyond










Types of Products we work with..



Main Categories

✿ Medical Devices (MD)
✿ In Vitro Diagnostics (IVD)
✿ Medicinal Products
✿ Companion Diagnostics
✿ Food & Food Supplements
✿ Veterinary Products







Biological Categories

✿ Recombination Products
✿ Monoclonal Antibodies
✿ Vaccines
✿ Blood and Blood components
✿ Cell/Tissue Therapy Products
✿ Xenotransplantation






Other Categories

✿ Combination Products
✿ Borderline Products
✿ Pediatric Drugs
✿ Orphan Drugs
✿ OTC Drugs
✿ Generic Drugs
✿Shortage Drugs
✿ Homeopathic Preparations
✿ Cosmetics
✿ Chemicals and Biocides

Our Expertise & Services in QA/RA extended to...


FSC
EAR
PRRC
FDA/EMA
AUDIT
LEGALISATION

The Certificate of Free Sale, also known as Free Sales Certificate, Certificate of Marketability, FSC or CFS

A European Authorised Representative may also be known as Authorized Representative (AR)

Person Responsible for Regulatory Compliance (PRRC)

The European Commission, the European Medicines Agency (EMA) and Food and Drug Administration (FDA)

A quality management system audit evaluates an organization's existing quality management system (QMS)

legalization is the process of authenticating or certifying a legal document so a foreign country's legal system will recognize



PRRC

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  • Person Responsible for Regulatory Compliance (PRRC)

EAR

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  • A European Authorised Representative may also be known as Authorized Representative (AR)