Gmp Formulations

Making Compliance Easy: We have been assisting companies in the pharmaceutical, natural health product, cannabis, dietary supplement, and medical device industries. We have learned that good advice comes from understanding that there is a difference between how the rules are written, interpreted and enforced. Anyone can read the rules, we understand the rules. Compliance Services: Our experts are able to assist you at every stage of a GMP compliance program for both the FDA and Health Canada. We provide a broad range of services designed to reduce the complexity and pressure of keeping your facilities and operations within compliance guidelines. Training Courses: Maintain Health Canada and FDA compliance with certified on-site GMP Training. Following our customizable training, you will receive all of the documentation to satisfy Health Canada including training records, test results, certificate of completion, and trainers CV. Regulatory Applications & Importing: The Regulated Product Launch Pad™ provides you with an easy to follow road map for getting your product onto North American and International Markets. Our experts can help you significantly reduce the time required to complete your accreditation and identify ways to ease the regulators approval of your product. With experience working with Health Canada, FDA, EU, ANVISA, and Minzdrav we can help get your product onto the global stage. Additional services Document Preparation (SOP'S, STP'S, URS) To perform Gap Assessment and Impact Assessment for Smoother transition towards GMP certifications. Protocol designing and review BMR, BPR review and approval QMS Designing Compliance Auditing (In house, External/Third Party, Investigators) Laboratory Set up (Area Qualification, Instrument Qualifications (IQ, OQ, PQ), Software Qualifications).