ALBERO is involved in Preparation and Registration of Dossiers that forms the integral part of marketing Authorization of Pharmaceutical Products.
This includes CTDs, ACTDs, eCTDs etc. for Tablets, Capsules, Injections, Metered Dose Inhalers, Dry Powder Inhalers, Nebulisers, Gels and Ointments and different dosage forms.
ALBERO has expertise in Preparing, Reviewing and Assessing the dossier of Pharmaceutical product which includes:
- Module 1 (Administrative and prescribing information that may be region specific)
- Module 2 (Summary of the Pharmaceutical Product)
- Module 3 (Includes overall detailed Quality summary of the Pharmaceutical Product)
- Module 4 (Non Clinical studies)
- Module 5 (Clinical studies)
ALBERO till today has successfully prepared the dossiers that lead to the marketing authorization by the Regulatory Agencies of the various countries.
ALBERO is also into the Preparation of SPC’s, Package information leaflets (PIL), Periodic Safety Update Reports (PSUR’s).
Every country has its own system and requirements in order to register a pharmaceutical or veterinary product. Although the required documents and procedures vary quite a bit most have many similar requirements for documents in order to ensure that the product being registered meet their standards for efficacy, safety and quality. To ensure quality standards are met, the appropriate regulatory authority in the intended drug market may request documents about the drug in question such as the COPP, FSC, Complete Registration certificates from other countries, Product Registration Dossier and others.
Good Manufacturing Practices (GMP)
A good manufacturing practices certificate show that the pharmaceutical manufacturing company has passed the inspection of the pharmaceutical regulatory body of that country and meets the standards of good manufacturing practices as stated by the WHO.
Certificate of Analysis (COA)
A certificate of Analysis is the document that shows the testing parameters of a pharmaceutical product according to the pharmacopeia in which the product was tested to adhere to. The COA shows each test and their correlating results alongside the results the pharmacopeia allows. An overall result of whether the pharmaceutical product passes or fails according to the pharmacopeia is listed at the bottom.
Certificate of a Pharmaceutical Product (COPP)
The COPP is the legal document that declares a certain manufacturing company is legally allowed to sell their pharmaceutical product in the country they are producing. When registering a pharmaceutical product overseas, the government body in charge of approving the application will usually require a COPP to ensure that the product is being sold as a commercial finished product in the country that is producing it.
Free Sales Certificate (FSC)
A Free Sales certificate is similar to a COPP where it enables a manufacturing company to list pharmaceutical products in which they can sell in the local market and internationally. A FSC, however can list multiple products at the same time.
A Dossier is required by most ministries in charge of the regulation of importation to ensure the process the manufacturer uses to produce a pharmaceutical product is an acceptable international standard. The Product Registration Dossier is a document that describes all the technical data related to the production, raw materials, standard, stability and quality of the products.The Dossier describes the origin, testing procedures and quality control of all the active and inactive pharmaceutical ingredients used in the production including their analysis.
The processing of the raw materials is described in detail including the process controls and the critical steps of intermediates. A Flow Diagram is typically used to show step by step the process the raw materials and excipients undergo in order to obtain the final product. The analysis of the final product is described in detail including the test results according to the pharmacopeia used for analysis. Full short and long term stability studies are also included to ensure the products can stand the test of time and the elements.