1. Woodley BioReg Limited
Company and Services Overview
WBR JAN 2016

2. Woodley BioReg Limited
WoodleyBioReg
 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

3. Company Background
WoodleyBioReg
 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………..

4. Services
WoodleyBioReg
 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
QualityRegulatory

5. WoodleyBioReg
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

6. Regulatory Affairs Support – Key Services
WoodleyBioReg
 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

7. Regulatory Affairs Support – Flexible Resourcing
WoodleyBioReg
 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

8. Regulatory Affairs Support – Registration Drift
WoodleyBioReg
Gap
Analysis
Load RemediationCollation
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.

9. Regulatory Affairs Support – Licence Makeover
WoodleyBioReg
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

10. Import Services
WoodleyBioReg
 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)

11. Quality Support
WoodleyBioReg
 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

12. Pharmacovigilence Support
WoodleyBioReg
 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

13. Training Services
WoodleyBioReg
 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

14. Areas of Expertise
WoodleyBioReg
 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)

15. Products WBR have Registered and Maintained
WoodleyBioReg
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

16. Current Global Projects
WoodleyBioReg
 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

17. 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