Who we help
Local Manufacturers
Sri Lankan companies manufacturing medical devices, cosmetics or borderline products.
Common difficulties
- Working out which manufacturing-site requirements apply, as they differ between cosmetics, devices and borderline products: NMRA site approval and GMP evidence for devices and borderline products, and NMRA acknowledgement with ISO 22716:2007 certification for cosmetics. See the three local pathways.
- Building a quality system that reflects how the site actually operates and stands up to inspection or certification.
- Planning certification, site approval and product registration in the right order.
How RAQ can assist
RAQ helps identify the site requirements, quality system and certification arrangements that apply to your products, supports documentation, gap assessments and audit preparation, and assists with the product registration route. Site approvals and inspections remain with the National Medicines Regulatory Authority (NMRA) where its procedures require them; for cosmetics manufacturing sites, the NMRA relies on ISO 22716:2007 certification by independent certification bodies, which also issue other ISO certificates.
Next step: tell us what you manufacture, your site's current approvals or certificates, and the products you plan to register.
Contact RAQ
Discuss your project
Tell us your role, the products involved and where they are made. We will reply with a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.