Authentication of document process can be complicated. We connect our clients to authentication services such as notarisation, legalisation, apostille of important documents including Free Sale Certificate and ISO certificates for submission to the authorities.
Factory setup
Connecting you directly to the Medtech and BioPharma Contractors for manufacturing facilities design and set-up in the Asia region. The contractor will work with the quality, process, risk assessment, system and software validation experts. The expert team consists of individuals that has experiences as the regulator and notified bodies auditor, and joined the biopharma and medtech industry.
Process Validation
We have a team of specialists that can assist on the Master Validation Plan, process verification and validation of manufacturing processes and practices to help your company complies with the local and international quality requirements such as GMP, US QSR and ISO13485.
Regulatory
Allow MedtechBOSS to manage and support you with medical device regulations in ASEAN, Asia and the rest of the world. We emphasize on the importance of having a good regulatory system to help you achieve the best results in the most efficient way. Our "one-stop service" business approach will guide medtech companies through every step of the regulatory process to achieve regulatory compliance.
Our regulatory services includes regulatory strategy planning, preparation of pre-market and post-market documents for submission to authorities, as well as structured procedures with the stakeholders, partners and distributors to meet the regulatory and quality requirements for the product and compliance to the authority.
Company Incorporation
We have connections to legal, company secretary and accountant to advise on the company set-up. Our team can link you with the appropriate leads to start a new business venture.
Should you need IT solution and government grant awareness information, you can talk directly with the relevant agencies.
Translation
We provide translation services for important documents to be used in the market required.
Distribution Search
Our extensive network can assist you in locating a suitable distributor in the market that you want to penetrate.
Support Service
Our dedicated support team will assist you whether regulatory or administrative work. We have been helping companies on-site or off-site as their department or temporary support team where they are in needs of help.
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