We facilitate worldwide regulatory needs for your brands. Our capabilities range from local & regional regulatory affairs, ingredient review, regulatory artwork and labelling, writing services, end-to-end submission & publishing, compliance, audit and validation for medical devices, pharmaceuticals/drugs, vitamin supplements, cosmetics, food and beverage. Our unique skillset and in-depth knowledge of industry issues can streamline your time to market.
Comply with Health Canada’s Regulations, where we will assist you in Classification, Claims Consultation, Site license application, and Regulatory Intelligence report for:
Natural Health Products (NHP)
Food & Beverage
OTC Drug (DIN)
Homeopathic Drugs (DIN-HM)
Veterinarian Health Care Products (VHP)
Consumer Chemicals and Containers Regulations (CCCR)
Pest Management Regulatory Agency (PMRA)
We offer FDA-related support, including Document Preparation/Reviews, Compliance Problem Resolution, Regulatory Affairs Strategic Assistance, Audits and Reviews.
Become COFEPRIS compliant. Our offerings include Strategic Regulatory Consulting, Regulatory Affairs & Regulatory intelligence, Market Authorizations, Good Compliance Practice (GCP), NTA to CTD conversions.
We assist you with end-to-end EFSA Regulatory procedures, such as Ingredients Assessment, Product Registration, Label and Claims Review, and Regulatory Strategy for the EU.
We make your ingredients safe and ensure that they meet MHRA requirements. We assist in determining your claims on packaging and advertising according to the MHRA regulations.
We ensure your business is compliant with Australian TGA regulations. We act as your TGA Compliance expert, assisting you to register your products with TGA and grow your business in Australia.
Redefine Regulatory Due Diligence for device Registration With NMPA, Regulatory Intelligence (RI). Get assistance in Labeling services, Translation services, Submission and liaison services with CFDA.
We will assist you in preparing the necessary Regulatory documents and submitting your applications to the Singaporean regulatory authorities. We will navigate you through the regulatory system of Singapore to obtain product registrations for medical devices, pharmaceuticals, cosmetics, food and supplements and OTC products.
Necessary registration and licensing processes in South Korea, we assist new market entrants, Device and Cosmetic manufacturers, to avail the maximum of opportunities by streamlining the methods of getting the Ministry of Food and Drug Safety (MFDS), formerly known as KFDA, approvals.