Prior to registration of a product, a number of liabilities and formalities are required to be fulfilled. It warrants time, data collation and compilation, filling of forms, etc. to avoid the long waiting in queue and hassle free resolutions. CliniExperts professionals are available at every step of this arduous process for you. We, at CliniExperts, are a one stop service solution provider to all your problems. We make every effort to attain complete client satisfaction so as to smooth the journey of a product launch. The pre-registration services provided by us include:
Results obtained from comparative in vitro studies such as dissolution or comparative in vivo studies (e.g. bioequivalence) that connect clinical formulations to the proposed commercial formulation (as described in 3.2.P.1 CTD Module) should be summarized and a cross reference to the studies (with study numbers) should be provided. Where attempts have been made to establish an in vitro/ in vivo correlation, the results of those studies, and a cross-reference to the studies (with study numbers), should also be provided in this section. A successful correlation can assist in the selection of appropriate dissolution acceptance criteria, and can potentially reduce the need for further bioequivalence studies following changes to the product or its manufacturing process.
CliniExperts extends complete and comprehensive guidance and support to obtain all the data required to file a data report.
We offer complete analytical method development, method validation and transfer services through a dedicated staff of knowledgeable and experienced pharmaceutical scientists. We have experience in support of various dosage forms within the generic and branded pharmaceutical industry. We also perform validation as per ICH guideline, which is acceptable to MOH/FDA of Asian, African, CIS, Latin American and Rest of World. We expertly handle all queries related to validation which are raised by MOH/FDA. As your research partner, we provide you a detailed protocol, report and chromatograms for method development and validation. In addition to this, we provide a report at the conclusion of each Validation project.
Included within this report is the analytical method itself which is written in a step-by-step format (which is acceptable at MOH/FDA during product registration). Analytical validation should comply with well accepted and established International Regulatory Standards & guidance of ICH / ASEAN / WHO / other country-specific guidelines.
Method Validation Services shall include method validation of the following: Test for Assay; Test for Dissolution; Test for Related Substance (impurities); Test for Identification. Types of Products include Pharmaceuticals Formulation, Bulk drugs (API).
We assist our customers by providing them search, selection & identification support for suitable comparator/ Reference Listed Drug product for the Generic applicants. If required, we can also arrange for the procurement & importation of the Innovator Products required for the Comparative studies such as In-vitro Dissolution testing and BE studies for the generation of development data required for Dossier Registrations with MOH/FDA.”
It deals with the collection of all technical information, assessment of technical information, follow up on additional data requests or clarification of data requests, reporting out of Technical Due Diligence. We have a skilled team under one roof for every pre-registration need for you in order to enable full support in regulatory & quality compliance services.
GMP site inspection is one of the mandatory requirements for obtaining the Registration Certificate by any Health Authority. We provide GMP consultation to proactively help our clients avoid issues with regulatory agencies. GMP consulting is often performed by doing gap assessment of the current quality systems and determining if there are any observations that expose them to enhanced regulatory scrutiny. CliniExperts also provides recommendations for remediation and will provide hands-on support with the implementation of remediation activities, as necessary.
We also provide a set of solutions unique to regulatory challenges faced due to Regulatory Health authorities’ inspections, due-diligence Quality/regulatory compliance audits and cGMP training etc.
CliniExperts Regulatory compliance services augment our clients’ internal capabilities to prepare for, execute and address compliance-related observations and deficiencies, thus mitigating our clients’ regulatory risk.