Scope
Small molecules
The experience level of the leadership members is used across all projects from any location. We also input into the development strategy the increasing relative benefit need of a new vs existing product as the regulatory and reimbursement scene changes.
Biologicals
An ex-FDA biological leader is the US based RegAff leader. With his colleagues, the coverage is all aspects of the dossier from the special CMC area to the strategy and needs for pre-clinical and clinical studies based on many years of reviewing dossiers in CBER.
OTC Switches
RegAff has devoted a large effort to the strategy and tactics of OTC switches and extensions of existing OTC products with a major company in the last two years in Europe and China. This includes developing switch strategies for existing prescription products as part of life cycle management, this includes POM to P as well as P to GSL in the UK. In addition we have been involved with developing the strategy and managing the EU registration of older US registered OTC medicines. Our resources include very experienced OTC leaders in the US, Europe and China.
Generics
Resources
The location of our generics expertise is currently UK based. Additionally, we have local based country experts in many of the ‘emerging markets’, in particular India and S. Korea that give us the local knowledge and ability to interact at a local level with Health Authorities. We are continually expanding this range of countries as client projects demand. Examples includes’ trouble-shooting’ when generic companies receive unexpected agency questions during the review process.
Examples of Capability
Strategic leadership
Accomplished regulatory affairs professional with 16 years experience and a record of achievement in leading generic pharmaceuticals and hospital products companies. Possesses in-depth knowledge of UK, Ireland and EU regulatory procedures, along with significant experience in Quality and Pharmacovigilance; also, headed up the local Quality Function in the UK, which mostly concerned GDP, labelling and document control; experience in handling MHRA GMP inspections, in relation to the MIA (for non-EU imports); managed Pharmacovigilance for the UK company; has experience in transfer of product manufacture in house or to third party sites.
Dossier creation and regulatory agency negotiation
Individual with 15 years of experience in the generics area; writing all sections of product dossiers, developing regulatory strategies, and in successful license submissions by the national, MRP and DCP procedures; many successes in getting customers to market at patent expiry when working for one of the world’s largest generic companies; excellent relationships have been developed with many of the European Regulatory Agencies, particularly UK, Ireland and Denmark; experience covers all therapeutic areas and dosage forms, most recent experience being in solid-dose products and injectable oncology products.
Individual with 20 years experience in EU and international regulatory affairs; experience spans the complete range of documentation required for Module 3; experience includes preparation and submission of duplicate applications and conversions of an old format (NTA) dossier to CTD format as well as the compilation of Module 3 documentation for established products involving the collection of relevant data through liaison with the manufacturing plant and local experts as well as extracting data from historical files; for many years part of a group involved with regulatory dossier preparation for use in markets in Central and Eastern Europe and Middle East and Africa across a wide range of pharmaceutical products.
RegAff experience includes numerous generic product strategies applied for using the European MR/DCP process.
Medical Devices
RegAff works with a well known leader in European device regulation who can advise on development strategies. Most recentactivities have been with a nasal spray device and a topical product.
License Maintenance
With the Pharmaceutical environment being about the need to reduce costs and improve efficiency even as the regulatory demands increases we offer a partnership model with resources at the central and/or country level. The outcome is that companies allow their internal resources to focus on growth products while at least reducing the fixed and high cost burden of license maintenance products. We have the experience of global labeling issues and delivering change conscious of the impact of one region/country on another particularly as transparency of regulatory decisions anywhere in the world increases.
As cost of goods reductions are essential to remain competitive, we believe we can help in reducing costs and maintain product profitability. We will work to:
- Obtain Variation Application Approvals to implement changes within a defined time period
- Provide a long term relationship and support authoring of complex variations across the portfolio
Compliance
RegAff has an ex-head of Global Compliance (GMP, GLP and GCP) in a top Pharma who has some 25 years of experience and obvious strong relationships with regulatory authorities.
Regulatory Documentation
Provide ‘plug in’ secure electronic regulatory documentation center tool using Microsoft Sharepoint software. This would include legacy documents for projects/products. It is a simple tool for non-Regulatory Affairs company personnel to access using company specific passwords.
Electronic Submissions
RegAff can provide cost efficient management of documents and electronic submissions to health authorities. This is facilitated by use of our own globally accessible, secure document repository (US or EU based servers and storage) for Clinical Trials Application, Marketing Application and other regulatory submissions.Our leadership in this area has a track record of many years of successful delivery. We are flexible to use allied companies where the workload is unexpectedly high.
The service includes:
- Preparation of electronic reports from legacy paper versions
- Conversion of existing dossiers into eCTD compliant including document repair
- Document template development for e reports
- E publishing and transmission of dossiers to regulatory authorities including the idiosyncrasies in Europe with DCP/MR submissions.