AM CONSULTANCY

AM Consultancy is a consultancy office, specializing in
GMP Audits for Pharmaceutical and Cosmetic Industry.
By Audit, AM Consultancy verify whether the drug or cosmetic manufacturer
or their suppliers work in accordance with the applicable regulations,
Good Manufacturing Principles and guidelines.

Pharmaceutical GMP Audits Cosmetic GMP Audits

Pharmaceutical GMP Audits

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.

Cosmetic GMP Audits

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.

Is it a Drug, a Cosmetic or Both ?

Whether a product is a drug or cosmetic by the law 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. Also for combination products, for example antiperspirants, makeup marketed with sun-protection claims, anti-dandruff shampoo etc. are specific guidelines and regulations in place.

Is it a Drug, a Cosmetic or both? This question has to be answered first before an audit against the applicable guidelines and regulations can take place.

References


Testimonials


Ms. Lambert audited our CDMO on behalf of 2 different MAHs. I really appreciated the professional deep competent approach without forgetting we are people and according to this concept the "sovoir-faire" should be something "mandatory". The various knowledge (pharmaceutical, cosmetic) was verified on the spot during the stay at our sites. In pharmaceutical area there are several different transfers, i.e. tech transfer, analytical method transfer etc.; Annemie transferred competence and cordiality.

Davide Valenti

I've known Annemie for over ten years. She combines the ability to convince people through her positive personality with a detailed knowledge of legislation, which makes the ideal person in any Quality Assurance role.

Bram Keymolen

Contact


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 in the right spot location.

If you require further information about the services offered by AM Consultancy, contact us directly by e-mail annemie.lambert@amconsultancy.be or by telephone 0032 486 21 92 12.