AM Consultancy is a consultancy office specialized in
GMP Audits for Pharmaceutical and Cosmetic Industry.
By Audit, AM Consultancy verifies whether the drug or cosmetic manufacturer or their suppliers work in accordance with the applicable regulations, Good Manufacturing Principles and guidelines.
AM Consultancy is a consultancy office specialized in GMP Audits for Pharmaceutical and Cosmetic Industry. By Audit, AM Consultancy verifies whether the drug or cosmetic manufacturer or their suppliers work in accordance with the applicable regulations, Good Manufacturing Principles and guidelines.
GMP compliance is required by OECD countries and cGMP is required by the United States FDA to ensure that proper guidelines are followed in the manufacturing of active pharmaceutical ingredients (APIs), excipients and finished drug formulations.
AM Consultancy assists in the review and implementation of GMP/cGMP compliance.
If your organization wants to sell cosmetic products anywhere in the world you need to meet the appropriate Cosmetic Good Manufacturing requirements. Cosmetics are regulated by the Federal Food, Drug and Cosmetic Act (FD&C Act) for the United States and have to comply to the European Regulation (EC) No 1223/2009 if sold in Europe.
AM Consultancy offers services to the cosmetic and personal care industry.
Whether a product is a drug or cosmetic or both is determined by a product’s intended use and the marketing authorization of the product into a specific market. Different laws and regulations apply to each type of product and market to be sold in. For example antiperspirants, makeup marketed with sun-protection claims, anti-dandruff shampoo etc.
This question has to be answered first before an audit against the applicable guidelines and regulations can take place.
AM Consultancy is a Belgian based company, originally founded as a Pharmaceutical Compliance Consultancy office, the company expanded the scope to the Cosmetic Industry in 2016. AM Consultancy offers services to the primary and secondary Pharmaceutical and Cosmetic Industries within Europe including third-party Audits.
Audit activities are performed by the owner of the company Annemie Lambert.
She started consultancy and Audit activities after a career of 20 years+ in Quality Control, Manufacturing and Quality Assurance Management roles in the Pharmaceutical Industry. From R&D to Operations , specialised in Sterile Manufacturing practices.
She holds a degree in clinical chemistry-microbiology and became a IRCA certified Lead Auditor since 2010. During her career she hosted several ISO , FDA and other regulatory GMP Inspection Audits.
AM Consultancy is based close to Brussels Airport and can reach out easily to other airports in the Netherlands, Germany or France. Traveling with high speed railway is another possibility to be on the right spot in a timely manner.
If you require further information about the services offered by AM Consultancy, please contact us by email with the Information Request form below, directly at email@example.com or by telephone +32 (0)486 219 212.