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5. Registration of medicines, auxiliary remedies and herbal drugs and medicinal devices in RS
 

5.1. PREPARATION OF DOCUMENTATION FOR THE MEDICINES REGISTRATION, REGISTRATION RE-NEWALS OR VARIATIONS AND PROCESSING APPLICATIONS ACCORDING NATIONAL (LOCAL) REQUIREMENTS AND PROCEDURES


5.1.1. Quality part for medicines - complete or partial development, preparation and/or compilation of documentation including consulting services to customers QC and Registration departments


5.1.2. Processing of developed quality part documentation in an authorized laboratory institution and collecting of verified certificates and analytical documentation for submitting as application for the registration to the liable authority.


5.1.3. Organization of (where appropriate) bioequivalence/bioavailability testing, monitoring and documentation preparation including verified expert opinion.


5.1.4. Clinical part - organization of (where appropriate) clinical testing and studies including clinical documentation preparation and/or preparation of verified clinical expert opinion.


5.1.5. Pharmacology part - preparation of an appropriate verified pharmacological expert opinion and verified patient leaflet


5.1.6. Regulatory affairs and representing of customer company as the applicant during complete process of preparation for registration and registration procedure in the liable authority.


 

5.2. PREPARATION OF DOCUMENTATION FOR THE AUXILIARY REMEDIES AND HERBAL DRUGS REGISTRATION, REGISTRATION RE-NEWALS OR VARIATIONS AND PROCESSING APPLICATIONS ACCORDING NATIONAL (LOCAL) REQUIREMENTS AND PROCEDURES

 

5.2.1. Quality part for remedies and herbals - complete or partial development, preparation and/or compilation of documentation including consulting services to customers Development, Manufacture, QC and Registration departments


5.2.2. Consulting and advisory services for development manufacture and control activities of the customer including pharmaceutical technology advising, analytical method development, quality assurance implementation, development of packaging, etc. Development or upgrade of the complete manufacturing process could be included.


5.2.3. Processing of developed quality part documentation in an authorized laboratory institution and collecting of verified certificates and analytical documentation for submitting as application for the registration to the liable authority.


5.2.4. Clinical part - organization of (where appropriate) clinical testing or reviewing including clinical documentation preparation and/or preparation of verified clinical expert opinion.


5.2.5. Pharmacology part - preparation of an appropriate verified pharmacological expert opinion and verified patient leaflet.


5.2.6. Regulatory affairs and representing of customer company as the applicant during complete process of preparation for registration and registration procedure in the liable authority.



5.3. PREPARATION OF DOCUMENTATION FOR THE MEDICAL DEVICES REGISTRATION, REGISTRATION RE-NEWALS OR VARIATIONS AND PROCESSING APPLICATIONS ACCORDING NATIONAL (DOMESTIC) REQUIREMENTS AND PROCEDURES


5.3.1. Quality part for devices - complete or partial development, preparation and/or compilation of documentation including consulting services to customers Development, Manufacture, QC and Registration departments


5.3.2. Consulting and advisory services for development manufacture and control activities of the customer including pharmaceutical technology advising, analytical method development, quality assurance implementation, development of packaging, etc. Development or upgrade of the complete manufacturing process could be included.


5.3.3. Processing of developed quality part documentation in an authorized laboratory institution and collecting of verified certificates and analytical documentation for submitting as application for the registration to the liable authority.


5.3.4. Processing of documentation for the registration according CE mark system (abridged applications for products bearing CE mark)


5.3.5. Clinical part - organization of (where appropriate) clinical testing or reviewing including clinical documentation preparation and/or preparation of verified clinical expert opinion.


5.3.6. Pharmacology part - preparation of an appropriate verified pharmacological expert opinion and verified patient leaflet


5.3.7. Regulatory affairs and representing of customer company as the applicant during complete process of preparation for registration and registration procedure with the liable authority.



Notice: Services listed under point 4. are also included for the point 5. but in the range as required by actual domestic regulations. If agreed so, simultaneous actions intended to produce documentation for domestic and international registration purposes (covering the both points 4 and 5) could be conducted.

Registration procedures assume compliance to GMP standards.
 

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