Regulatory Affairs

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It is difficult to separate regulatory issues from quality assurance. Because of this, MedWatch Global provides you with everything you need.

We support you throughout the entire life cycle of your products, whether they are conventional pharmaceutical products, generic medications, vaccines, biologicals, biosimilars, medical devices, or Advanced Therapy Medicinal Products, in addition to taking care of quality management. (ATMP).

Our consultants can support your team or insource entire regulatory affairs projects with their extensive knowledge and practical experience, all in a timely and effective way.

Our Regulatory Affairs Services

Regulatory Affairs for Pharma and Biotech

For the pharmaceutical and biotech industries, regulation criteria is crucial because it makes sure that products are developed and sold in accordance with regulatory requirements.

Regulatory Affairs for Medical Devices

Need assistance with regulatory issues for your medical device? We provide the direction you require to follow intricate regulation requirements.

Performance Evaluation Studies

Does your IVD device require appropriate clinical evidence? With regard to your IVD Performance Evaluation Studies, we are glad to assist you.

In-country Representative Services

Does your medical equipment and/or IVDs require representative services? Independent collaborator MedWatch Global can serve as an EC-REP, CH-REP, or UKRP.

Legal Representative Clinical Trials

Do you want to run a clinical trial as a sponsor? You may have MedWatch Global defend you in legal matters.

Person Responsible for Regulatory Compliance (PRRC)

Are you trying to find a PRRC (Person Responsible for Regulatory Compliance) for your IVDs and/or medical devices and therapeutic goods?

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Call / WhatsApp: 03011121706 - 03018470344
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