AlphaPharma Consulting has over 25 years experience in implementing current Good Manufacturing Practice (cGMP) requirements for international pharmaceutical, biotechnology and active pharmaceutical ingredient companies. Based in Bangkok, Thailand, AlphaPharma is ideally located for companies in the Asian region.
AlphaPharma has worked with many Companies in Asia, especially India, to effectively implement and maintain Regulatory Standards of:
US FDA MCA (now MHRA) TGA MCC WHO Schedule M, India
Companies manufacturing formulated pharmaceutical products (sterile and nonsterile), biotechnology products and active pharmaceutical ingredients (API's) for home and overseas markets must meet prescribed standards of Current Good Manufacturing Practice (cGMP). To effectively implement and meet regulatory requirements associated with these standards, AlphaPharma offers consulting services covering the following.
Current Good Manufacturing Practice (cGMP) Quality Management, covering all aspects of Good Laboratory Practice (GLP) Validation and Qualification Regulatory Agency Documentation
Mr. Derek Smith, the principal consultant of AlphaPharma Consulting, has held management positions in the pharmaceutical industry in a number of countries. In addition to industry experience, he also worked for the Therapeutic Goods Administration (TGA) of Australia as a senior GMP auditor and was responsible for conducting GMP and Quality System audits of companies both at home and overseas.
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