Pre-registration

Pre-registration

 

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:

 

1. Data Generation and Data Review w.r.t Drug Substance and Drug Product Drug master file (DMF)

 

• Generic Product Development as per Country Requirements: We assist our clients in development of new products and data generation in line with country specific registration guidelines. We have expertise in creating guidelines for both regulated and semi-regulated markets.

 

• Development & Preparation of R&D documents: We provide guidance in development & preparation of R&D documents, g. AMV Protocols, Reports, Stability protocols, Reports, PDR in CTD (ASEAN, EU or ICH) format.

 

• Dissolution Comparative Studies Designing and Data Report: A valid in-vitro and in-vivo correlation (IVIVC) directly influences the dissolution rate of a product. Dissolution testing for a formulation as well as its modified version is essential as a function of product optimization. It reduces the further need of additional bioavailability/ bio-equivalency studies.

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.

• AM development and Validation as per ICH Q2A, Q2B:

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).

• BA/BE studies: Planning, NOC for BE, Conducting Bioequivalence (BE) and Bioavailability (BA) Studies with well-known CROs are also deftly handled by our team of experienced professionals.

 

• Reference Listed Drug (RLD)/Innovator Product/Comparator: We extend our support for Procurement, Importation, IL & TL application till approval.

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.”

2. Regulatory & Quality Compliance Services & Expert Reports

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 Audits/Site Due Diligence- API Site, FP Sites: We take care of preparation of sites for the GMP compliance for registration, due diligence for QMS and regulatory documents, providing observation/audit reports, preparation and submission of CAPA to Health Authorities.

 

• Assessment of Regulatory documents/Existing dossier: We offer due diligence with respect to Existing Dossier and technical data for the Dossier preparation. The documents and data are evaluated as per the country specific requirements. The evaluation report is then submitted to assist Client’s technical Team for necessary action and further planning. We assist and closely work with the technical team to write the documents, use the regulatory compliant formats & while working with them closely monitor to fill the gaps for better Regulatory & Quality compliance. This will not only help to minimize the queries raised during dossier assessment, but also keep check on the related Quality documents during GMP inspection by Country Health Authorities/MOH.

 

• Regulatory Compliance of Manufacturing Sites for GMP compliance: At CliniExperts, our compliance consultants have a strong working knowledge of requirements and can help implement the necessary quality systems to meet the regulations. Additionally, we have substantial experience helping clients with remediation when their quality systems implementation and management fall short of meeting regulatory requirements.

 

• GMP Assessment and Due Diligence Analysis:

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.

• We also cater Gap analysis facilities on the existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa.

 

• CliniExperts provides guidance & assistance by working closely with the technical team of clients towards the generation of adequate data for successful submission of the Dossier to Country MOH/Health authorities.