Pharma ACTD Dossiers

Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission. Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations. Medical and Clinical Consulting Consulting on the Complete Product Development Program (all phases) Reviewing and Assessing Clinical Protocols Reviewing Safety and Efficacy Related Issues During Product Development Adjudicating Clinical Data Worldwide Drug Safety and Pharmacovigilance Services Clinical Trial Safety Services Post-Marketing Surveillance Services Pharmacovigilance ...

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent. Good documentation practice  (commonly abbreviated  GDP , recommended to abbreviate as  GDocP  to distinguish from "good  distribution  practice" also abbreviated GDP) is a term in the  pharmaceutical and medical device industries  to describe standards by which  documents  are created and maintained. What to write, and how to GDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FD...

GMP- GOOD MANUFACTURING PRACTICES Good manufacturing practices  ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of  food  and  beverages ,   cosmetics ,   pharmaceutical products ,  dietary supplements,  and  medical devices . All guideline follows a few basic principles: Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use. Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the pro...