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OUR PARTNERSHIP SOLUTIONS
Preclinical / Clinical Development / Medical Affairs
Reguclin will partner with you and provide strategic inputs at the product selection stage so that your business case remains positive throughout the development and in post-registration era. Thorough medical and regulatory landscaping, new medicinal product identification (portfolio selection), creation of target product profile, strong literature review, robust designing of preclinical and clinical development strategy, study execution at the qualified CRO unit/hospital sites and quality oversight/management will help you achieve on-time regulatory filing, early product approval and commercial launch. We also offer best pricing model for contract pharmaceutical physician services.
Medical Writing & Pharmacovigilance
Our key objective is to help clients by preparing clear and comprehensive non-clinical and clinical overviews for regulatory dossier (modules 2.4, 2.5, 2.6 and 2.7), Addendum to Clinical Overview as part of renewals, Pediatric Investigation/Study Plan, Orphan drug designation dossier, clinical study documents (Protocol, Investigators Brochure, Informed Consent Form, Case Report Form, Clinical Study Report), manuscripts for publications, posters and abstracts for presentation, pre-IND meeting package, regulatory communications including briefing books for scientific advice meetings, and PV documents such as PV SOPs, PSMF, PSUR/PBRER, PADERs, DSUR, RMP and REMS. Reguclin offers competitive pricing for medical writing and end-to-end PV services to the preferred partners with a strong commitment to the quality of documents. We can support you to establish and maintain company's PV system through the provision of appropriately qualified, trained and experienced EU QPPV.
Due Diligence
Given the increasing complexities of drug development, stringent regulatory requirements from most healthcare authorities and increasing clinical development costs, day by day it is becoming more and more challenging for small and medium sized enterprises to invest into new product developments. Business alliances and co-developments are becoming increasingly popular. Reguclin supports clients with clinical due diligence and gap analysis activities for in-licensing opportunities.
Trainings
Reguclin Consulting offers training courses on topics including clinical development, medical writing and pharmacovigilance. These programmes can be customized as per the organization's needs. In addition to online training sessions, Reguclin is also able to conduct in-person workshops at the company sites.
Scientific Advice
One of the key challenges in global clinical development of new products, whether new therapeutic entities or complex generics, is the diversity in nonclinical and clinical requirements for the same product from different healthcare regulators. At times, there are uncertainties despite regulatory guidance documents. In such cases, Reguclin partners with you to navigate this situation, design strategic development plan and even represent you at the scientific advice meetings with the regulators.
Monitoring, GxP and Auditing
At every stage of medicinal product development, it is critical to ensure that the systems and processes follow good practice (GxP) guidelines and meet the quality standards of healthcare regulators. Reguclin helps clients especially small and medium-sized organizations in designing the Clinical and PV SOPs, qualifying preclinical/clinical CRO partners, providing clinical study monitoring support, performing sponsor-independent GCP/GVP audits, reviewing medico-marketing material in accordance with the code of GPP, triggering GMP audits, mock BIMO inspection for FDA, preparing for other regulatory inspections and even supporting remediation activities. Reguclin also provides third party audit services for API/FP plant, KSM vendor, excipient supplier and packaging vendors.
Regulatory Affairs
Reguclin can help you with the regulatory support at the every stage of product development life cycle: pre-approval regulatory solutions including regulatory submission strategy, dossier & DMF drafting, dossier & DMF gap analysis, deficiency response handling and dossier submission management; and post-approval solutions including life cycle maintenance in the Europe & US and preparation of the renewal application package for Europe. Our regulatory experts are also able to help you with readability testing, artwork creation for leaflet, carton and blister, drafting of SmPC, leaflet & labeling, MA holding in Europe; and eCTD publishing (US, Europe, Australia, Canada and EAEU countries).
Pharmaceutical Translations
In certain countries such as CIS, GCC, Francophone countries, the drug master file (DMF) and the drug product dossier need to be translated into country specific language. Reguclin has also built a network of certified translators who have proven track record of translating and proof-reading your dossier into any language of your choice as per the regulatory or market needs of the pharmaceutical product. High-quality translation and localization services can be provided in over 50+ languages by Reguclin even for medico-marketing purposes, thereby promoting your company brand, and connecting you with your customers.
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