Early Access Programs are country-specific regulatory tools that allow a drug to be available on the market before its official launch, providing that it fulfils specific criteria. Despite potential significant advantages of these programs, many pharma/biotech companies remain unaware of the possibilities available in Europe.
In addition, even amongst the informed minority, many assume - wrongly - that an EAP will be too risky, too complicated or too costly to consider. “Reaching new patients in new markets quicker”
Named Patient Programs (NPP)
Named Patient Programs (NPP) allow sponsors to make their drugs available to patients in countries where they are not yet approved. This can help sponsors reach new markets, engage with KOLs, and ultimately expand the use of its products. To successfully run an NPP, sponsors will need to understand the complexities involved in moving into new markets before marketing approval is received.
At Pharmackt, we pride ourselves on being able to distribute product to countries all around the world in the most efficient and regulatory compliant manner possible. We use our extensive experience to help you bridge the gap before commercialization rights are received.
Pharmackt can provide guidance on: Developing a policy for allowing access to medicines in countries where they are not yet approved Consistency across different territories Managing patient requests and expectations Navigating the diverse, global regulatory landscape Managing the logistics of distributing product around the world Mitigating risks and any potential legal issues
Clinical Trail Support (CRO Services)
Creation or coordination of the production of necessary trial documentation, including protocols, subject information and informed consent, Investigator’s Brochure and IMPD. Management of all aspects of study medication. Identification and selection of the best clinics or Contract Research Organizations (CROs) for the needs of the protocol, clear of any selection bias.
Pharmackt will select the best sites with the clinical expertise related to your study. Writing and submission of the clinical trial application and management of other regulatory aspects of the study Supervision by clinical trial team during preparation, execution and reporting phase Coordination of communication with CRO’s and other partners regarding timelines, budget and quality of the clinical trial Pharmacovigilance Data management GCP monitoring Statistics, analysis and reporting
Preparation for GMP
Preparation of application forms for imported and domestic product licenses Preparation of export licenses files Preparing a commonly marketed product file Preparation of licenses transfer dossier Preparation of GMP files for imported products Preparation of change files for products that have been registered or have been registered
Preparation of license renewal files Preparing product information and instructions for use of a medicinal product of human use (from existing approved KÜB ve KT or original existing product prospect Preparation of bioequivalence summary report Preparation of 4 clinical expert reports
Medical devices preparation of application documents of medical devices with CE certificate and registration to the Turkish National Data Bank of Drugs and Medical Devices (TITUBB). Food supplies Preparation and follow-up of the application form for permission for food subsidies.
Veterinary medical products In accordance with the current regulations, guidelines and announcements issued by the Ministry of Agriculture, applications for veterinary medicinal products in accordance with the company's requests are prepared electronically or in the form of a written copy. The necessary information and documents for the application of marketing permission of the transactions related to veterinary medicinal products is prepared in accordance with the relevant legislation. It will be presented to the Ministry in an electronic environment.
Applications for marketing authorization, renewal applications, all variations apply, product specification summary and prospectus preparation.