Woodley BioReg Limited

Company and Services Overview

WBR JAN 2016

Woodley BioReg Limited W

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Company Background

Services Regulatory Affairs Support

Quality Support

Import Services

Training Services

Areas of Expertise Examples of Products Registered and Maintained by WBR

Examples of Current Global Projects

Company Background W

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Established in 2001

Headquarters in the UK

Permanent Employees reinforced by a network of Specialist Associates

Operate Globally Europe, USA, India, China, South Korea Australia………..

Services W

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Provide Regulatory, Quality, Import Services and Training

Work with you, the manufacturers and suppliers of:

Biopharmaceuticals / biologics / biosimilars

Pharmaceuticals

Generics

Healthcare / Over-the-Counter Medicines

Active Pharmaceutical Ingredients (APIs)

Medical Devices

Training Import

Services Quality Regulatory

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Overview of EU cGMP Registration Process

Registration cGMP

Gap Analysis

Audit Technical Plant/

Documents

Review/Finalise

Submission

Draft Submission

Submit (Nees / eCTD)

to BoH / EMA

EU Audit

Approval

Market Product

Remediation Report

Remediation Deficiencies

Audit and Approval

Maintain cGMP

Compliance

Existing Reg.

Affairs Docs

Regulatory Affairs Support – Key Services W

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Flexible Resourcing Day-to day support for function activities

Qualified resources with 2 to 25+ years of experience

Ex-Industry, ex-Agency (MHRA, BfArM, EMA, Health Canada, FDA, etc.)

Registration Drift MA compliance and conformance assessment

Agency “approved” dossier review and remediation procedure - published

Applied to over 8,000 MAs

Permanent fix that link the MAs into change control procedures

Licence Makeover Allows easy maintenance of well-established products

Simplifies variations

Can be combined with other initiatives, e.g. Registration Drift

Import Service Allows non-EU clients to make a soft landing for EU commercialisation

Regulatory Affairs Support – Flexible Resourcing W

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Submission Strategy Development DCP / MRP / CP / duplicate licences / COO etc.

Write and submit Marketing Authorisations / Product Licences m1 through to m5

Publishing - NeeS (EU) or eCTD (US)

Respond to Requests for Information (RFIs)

Attend Agency Meetings with Boards of Health (and Scientific Advice)

Licence Maintenance / Life-Cycle Management Change of ownership

Variations and Renewals

Compliance and Conformance specialists for top tier pharmaceutical companies

Provide EU Regulatory Affairs office for overseas (non-EU) clients

Regulatory Affairs Support – Registration Drift W

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Gap

Analysis Load Remediation Collation

Risk-based

Schedule

Prioritise products, collect MAs,

collate details in a single central

location, and prepare to perform

a GAP ANALYSIS

Prepare and file variations to

align the MAs and maintain under

Change Control

Compare MA sections to Plant /

Manufacturing documents, prioritise

the differences.

Regulatory Affairs Support – Licence Makeover W

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3.2.P.1

DS

DP

PDF NtA

Scans

PDF NtA

Scans

PDF NtA

Scans

Paper PDF NtA

Scans Variations

3.2.S.1

eRepository

Current MAs, Variations, etc

Extracted and organised into CTD (DS / DP) folders

Compliance and Conformance reviewed CTD / SRC dossier sections

MA Visibility / Maintenance (under CC)

Extraction Reformat & Review

Extraction 1. Take source documents, Scan/OCR 2. Split into DS / DP sections 3. No rewriting undertaken

Reformat & Review 1. Convert into CTD format (templated) 2. Re-write parts as necessary 3. Review content against CTD requirements 4. Identify Gaps / Remediate through variation

Load

- WBR / Client for Scan / OCR (where available)

- WBR for load - Client for ongoing

maintenance

- WBR for review, reformatting and Gap Analysis

Import Services W

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Provide EU address

Laboratory Testing Services: Full release

Batch release

Identity

Product quality specification (PQS)

Stability - storage (temperature and humidity controls) and indicating

QP sign-off for batch release

PV contact for Adverse Event reporting (see later)

Secure, controlled storage of GMP pharmaceutical products

Shipping and distribution within the EU

All of the above services are EU legal requirements governed by Manufacturer’s Importer’s Authorisation (MIA)

Wholesale Dealers Licence (WDL)

Quality Support W

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cGMP standards and certification (EU and US) Contract QP services (biologics and pharmaceuticals including steriles)

Full validation and documentation assessment and remediation / re-writes

Issue WBR EU registered QP certificate

Quality Management / Quality Assurance System Development, refinement/ amendment and deployment of QMS

Pharmacovigilence Including contract QPPV services

Auditing Self-Audits

Due diligence

Third party manufacturers

Remediation plans and assistance

Training GMP and Regulatory Affairs

Pharmacovigilence Support W

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EU QPPV Provision

Pharmacovigilance System Master File (PSMF) generation and maintenance

Receipt and processing of Serious Adverse Events (SAE) onto ARISg

Medical Review of ADR reports and submission of expedited reports

Literature searches (required for PV reporting)

Periodic Safety Updates (PSURs) preparation and distribution of Risk Management Plans (RMPs)

Signal detection

EVMPD (PV database) maintenance

Audits, training and any other incidentals

Training Services W

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cGMP and Quality Systems Requirements

Regulatory Affairs Submissions

New Variation Guidelines

Introduction to European Regulatory Affairs

How to Register Biosimilars to “Global Standards”

Pre-approval Inspection Requirements for the US FDA

How to Audit to cGMP - what to look for in self-audits

Identification and Validation of Critical Manufacturing Process Steps

Areas of Expertise W

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Biologics / Vaccines

Biosimilars

Pharmaceuticals / Generics

Healthcare / OTC

Devices (including Drug Device combinations)

Steriles including pre-filled syringes

Advanced Therapeutic Medicinal Products (ATMPs)

Orphan Products

Metered Dose Inhalers

Solid dose, gels, and capsules

Topicals (creams and ointments)

Products WBR have Registered and Maintained W

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Examples of products WBR registered and maintained in the EU and US:

Alpha-reductus Inhibitors

Analgesic

Anti-anxiety

Antibiotic

Anticholinesterase

Anticonvulsants

Antidepressants

Anti-epileptic

Antihypertensive

Antihistamines

Anti-platlets

Antipsychotic

Bi-phosphonates

Cholinesterase Inhibitors

Diuretics

Immunosuppressants

Laxatives

Leukotriene Receptor Antagonists (Asthma)

Meglitinides (Diabetes)

Oncology

Proton Pump Inhibitors

Sedatives

Statins

Steroids

Vaccines

Anthrax

Diphtheria

Hepatitis B

Influenza

Meninge

Pertussis

Tetanus

Typhoid

Yellow Fever

Vitamin D products

Current Global Projects W

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EU and US Registrations Statins / Anti-depressants / Anti-hypertensives / Analgesics / Combination products /

Vaccines etc.

For Chinese and Indian generics manufacturers

EU Regulatory and Quality department Long-term provision of EU “virtual” regulatory department for an Indian generics

manufacturer

Submission of all filings to EU Boards of Health

Quality Management System (QMS) implementation Scoping, writing, implementation and ongoing management of a QMS for the UK division

of a Chinese international generics manufacturer

Global Conformance Review Review of >2,000 over-the-counter healthcare products for a multi-national

pharmaceutical company

Quality Audit of a Manufacturer Due diligence audit of a Korean biologics manufacturing company prior to US acquisition

Regulatory and Quality Experts

www.woodleybioreg.com

E: enquiry@woodleybioreg.com

T: +44 (0)1484 434343 Midland Mill, 9-11 Hillhouse Lane, Huddersfield, West Yorkshire, HD1 6EF, UK