Areas of expertise

Stay compliant with your Pharmacovigilance, Regulatory and Quality requirements.

Strategic Consulting Services:

At RegVision Pharma Consulting, we offer comprehensive strategic consulting services that spans the entire pharmaceutical product lifecycle. From the early stages of discovery, through Phase 1 clinical trials, IND/IMPD/CTA submissions, all the way to the final registration phases (MAA/BLA/NDA), we provide expert guidance and support.

Our seasoned team is well-versed in facilitating pre-registration assessments, preparing submission dossiers, conducting in-depth reviews for compliance and conformance, and managing the entire submission process. We excel in orchestrating interactions with Health Authorities, ensuring a smooth journey right up to final approval.

Experienced in US and EU initial submissions (Module 1 - Module 5), encompassing both small and large molecules, we have a proven track record of successfully guiding clients through the NDA/BLA and MRP/DCP process routes, as well as National Procedures

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Operational Consulting Solutions:

At RegVision, we recognize the substantial workload associated with submission, maintenance, post-registration tasks, and product launches. This workload often creates a significant industry-wide challenge, as clients and partners find it challenging to maintain an expert in-house team on an ongoing basis.

Moreover, the regulatory landscape is in a constant state of evolution, with new guidelines, changing submission requirements, and complex regulatory content. This dynamic environment can make it exceptionally difficult to ensure ongoing compliance with maintenance activities.

We take pride in offering a comprehensive solution to address these challenges. Our team is fully equipped to manage these critical activities for your projects, providing compliant and quality-driven solutions. From variations and renewals to labelling changes, safety submissions, and database maintenance, we deliver the expertise needed to ensure your ongoing regulatory success.

CMC Expertise

At RegVision, we provide a premium solution for the development of CMC (Chemistry, Manufacturing, and Controls) dossiers across a diverse spectrum of business portfolios, including pharmaceuticals, biotechnology, vaccines, ATMP/GTMP. Our services encompass everything from crafting initial marketing authorization applications to conducting thorough dossier authoring for compliance and conformance gap analysis.

Our team of experts is proficient in managing CMC authoring for various components, including Drug Substance, Drug Product, Analytical, and administrative dossier sections. We adhere to the rigorous standards of ICH-CTD or tailor our approach to align with your company's defined templates.

Furthermore, we offer a tailored solution to oversee Change Controls within established systems such as TrackWise, Veeva Vault, or equivalent platforms. This end-to-end service encompasses Change Initiation, Change Control Impact Assessment, and meticulous tracking of changes until successful implementation.

Our dedicated consultancy team is well-equipped to handle your operational requirements related to Module Certificates and Statements, covering GMP, MLs, CEPs, CPPs, ASMF/DMFs, LoAs, PoAs, as well as country-specific statements and declarations. Partner with us for a comprehensive CMC expertise which can be tailored to match your specific needs.

Vaccines

Our invaluable experience in the vaccines sector was garnered while collaborating with major clients, enabling the maintenance of vital licenses during the COVID-19 pandemic. This unique experience positioned us to engage directly with prominent global organizations such as the WHO, EMA, FDA and international markets.

We have a proven track record of delivering up-to-date information in response to various requests and commitments. Our expertise extends to managing numerous dossiers on a global scale and providing timely and insightful responses to critical inquiries.

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Brexit

As of 01 January 2021, compliance with the new MHRA (Medicines and Healthcare products Regulatory Agency) guidance for the industry became imperative. This guidance supersedes the previously issued directives concerning actions to take following the end of the transition period.

Our comprehensive Brexit review primarily focuses on licensing changes, encompassing the following key areas:

·       Existing Marketing Authorizations (MAs) and New Mutual Recognition Procedures (MAAs)

·       MHRA Approach to Approved or Pending Decentralized Procedures (DCPs) and Mutual Recognition Procedures (MRPs)

·       Centrally Authorised Products (CAPs)

·       Variations

·       Renewals

·       Marketing Authorization Holder (MAH) and Qualified Person Responsible for Pharmacovigilance (QPPV) Location

·       Artwork, Labelling and Packaging Requirements

Our distinction lies in the fact that one of our lead consultants was engaged by the Association of the British Pharmaceutical Industry (ABPI) to collaborate with the UK Government and MHRA in regulating the new legislations. The knowledge and insight gained from this endeavour was subsequently shared with all Heads of Regulatory for ABPI member companies in the UK. This exemplifies our exceptional in-house expertise and unwavering commitment to keeping abreast of all Brexit-related developments and activities.

Start-ups

Our expertise extends to supporting startups in the pharmaceutical arena. We have a proven track record of helping emerging innovative medicine manufacturers establish robust regulatory affairs departments.

Our services encompass:

·       Crafting comprehensive Regulatory Strategy Plans tailored to the unique needs of startups.

·       Facilitating the selection of Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and Regulatory Partners crucial for initiating the regulatory journey.

Partner with us to kickstart your regulatory journey and navigate the path to success in the dynamic world of pharmaceutical innovation”.

Clinical Expertise

Our clinical experts excel in various facets of the pharmaceutical development journey. Our services

encompass:

  • Authoring, managing, and submitting Clinical Trial Authorization (CTA) Applications,

Investigational Medicinal Product Dossiers (IMPDs), Paediatric Investigation Plans (PIPs),

Investigational New Drug (IND) Applications, and Orphan Drug Designation (ODD) applications to

the relevant Ethics and Health Authorities.

  • Authoring and reviewing Clinical Development Plans, IMPDs, briefing books, Risk Management

Plans (RMPs), and PIPs/PIP modifications tailored to both EU and global markets.

  • Efficiently managing clinical trials, including the submission of initial applications, substantial

amendments, notifications, and end-of-trial processes.

  • Navigating the complex regulatory landscape with expertise in leading Pre-submission Meetings

with the European Medicines Agency (EMA) and spearheading ODD applications for orphan

indications across multiple clients and products.

Our commitment to excellence in clinical affairs ensures the successful development of ongoing and

future trials, bringing valuable therapies to patients.