business & product development services - ginsana sa · pdf filebusiness & product...
TRANSCRIPT
Swiss excellence
a Boehringer IngelheimGroup company
Postal address:Ginsana SAPO Box 2656934 BioggioSwitzerland
Premises:Via MuliniCH-6934 Bioggio
Telephone: +41 91 610 31 11Fax: +41 91 610 32 09Email: [email protected]: www.ginsana-sa.com
Ginsana IB manages itsactivities in an ethical
manner and is committed toa sustainable development.
© 2012 Ginsana IBPrinted on Satinat Green,
a recycled coated paperwhich meets the latest envi-
ronmental standards.
Business & ProductDevelopment Services
Invaluable scientificsolutions for nutraceutical,pharmaceutical andcosmetic companies
GBI_copertina_4x_IND3.indd 2 25.4.2012 11:42:24 Uhr
Bringing ideas to lifeWe built our Swiss pharmaceutical company on one idea born over 70 years ago, so we know fi rst hand the enormous potential of ideas.Our success, accumulated experience and expertise, means we are able to offer a complete range of manufacturing faci-lities and services to others who wish to bring their ideas to life. We are evolving as a viable business entity based on a consolidated business model and recognized as a leading, highly competitive, full service pharmaceutical and nutraceu-tical contract manufacturing and services company.We offer a personalized service which encompasses the entire range of the value chain, from product development to distribution of fi nished goods. In addition we can provide you with a broad range of analytical and microbiological analyses services.Ginsana Industrial Business (Ginsana IB) allows you to reali-ze your idea quickly, thoroughly and effectively. We look for-ward to supporting you in reaching your goals.
Dr Valter GianeselloDirector of OperationsDr Valter GianeselloDr Valter GianeselloDirector of OperationsDirector of Operations
Our products’effi cacy andsafety are scien-tifi cally proven.
InnovativeDevelopment
DRA
Medicine
R&D
Business & Product Development ServicesGinsana IB provides a very attractive combination of pharma and nutra- ceutical expertise to leverage your own business needs.
Our expertise lies in
Our expertiseis the officialstamp ofpremiumness.
For additional information pleaserefer to the charts at the end.
Projects and Scientific Services There are several kinds of approaches we can follow depending on the customer’s needs. They range between the development of pharmaceutical forms according to specific requests and the tailor made and accompanying service approach on the basis of the customer’s generic needs.
Innovative development
We develop your idea, and our R&D department accompanies it with a full range of services.
Robust data and documentation are delivered so it is easier for you to take the right decisions.
We also ensure registration procedures and link them to manufactu- ring and worldwide product supply.
We offer scientific services in the following key areas:
Product Development R&D Medicine Regulatory Affairs
Medicine
Scientific evaluationand support
Clinical Trials
Drug and food compositions Ingredient analysis for mono and multi preparations Literature search Product development, maintenance and registration
purposes
Clinical development plan (CDP) Planning of clinical trials (GCP) Planning of tolerability studies (GCP) Prepare investigation’s brochures
NTA 2B, CTD-Module 5 Clinical Study Reports NTA 2B, CTD-Module 2.5 Clinical Overview NTA 2B, CTD-Module 2.7 Clinical Summaries
Product Development
Regulatory Summary
Pharmacology /Toxicology Summary
PharmaceuticalDevelopment Summary
Operations Summary
Clinical Summary
Project Plan
Registration strategy for key countries Dossier requirements
Pharmacology and pharmacodynamics Pharmacokinetic profile / Toxicology
Drug substance and drug product Patent situation
Manufacturing considerations
Clinical evaluation on efficacy and safety Clinical development plan
Product DevelopmentEvaluation
TargetProduct Profile
Marketing Summary
Market assessment Competitive environment Objectives and degree of innovation Pharmaceutical aspects and key elements Preclinical aspects Medical evaluation Registration strategy / Regulatory positioning Pricing (net price) Life cycle management
Project idea (differentiation potential / USP, market attractiveness and relevant countries) Market and competition / Worldwide overview Pricing (net price) Qualitative research data
Research & Development
Main GalenicalLaboratoriesEquipments
Rotary tablet press equipped with 8 stations Tablet pan coater (lab and pilot scale) Hard gelatin capsules filling machine Lab scale (homogenizer vacuum processing unit) Multi-purpose lab equipment with grinders,
kneader, homogenizer, mixers Angle of static repose equipment Laser diffraction particle size analyser Microscope with digital photo camera Hardness and friability tester Viscosimeter and turbidimeter
Research & Development
Main AnalyticalLaboratoriesEquipments
High Pressure Liquid Chromatography (HPLC) with the following detectors:
- Variable wavelength - Diode array - Fluorescence - Refractive index - ELSD - MS (single – quadrupole)
Inductively Coupled Plasma Optical Emission Spectometry (ICP-OES) Atomic Absorption Spectrometry (AAS) Dissolution apparatus
Research & Development
Galenicaland AnalyticalDevelopment
First assessment of feasibility based on our experience in formulations Characterisation, evaluation, choice and
assessment of raw materials Preformulation and formulation studies Reformulations of products in liquid, semi-solid
and solid forms Development and validation of analytical
methods (ICH) Microbiological analysis and challenge tests Pilot, industrial batches and clinical batches Stress tests and ICH stability studies
NTA 2B, CTD-Module 3 Quality Chemical-pharma- ceutical and biological Documentation for activesubstances and biological medicinal products.NTA 2B, CTD-Module2.3. Quality OverallSummary
Research & Development
Galenicaland AnalyticalDevelopment
Literature search in databases Specific toxicological and pharmacological studies
NTA 2B, CTD-Module 4 Nonclinical Study ReportsNTA 2B, CTD-Module 2.4 Nonclinical OverviewNTA 2B, CTD-Module 2.6 Nonclinical Summaries
Regulatory Affairs
RegulatoryAssessment
Documentation
RegulatorySubmission
Submission strategy / drug products, food supplements Suitability of claims
NTA 2B, CTD-Module 1–5 for the registration submission Reformatting of NtA 98 dossiers in CTD
(quality part) Drug master file for API
Consultancy before submission of dossiers Support for interaction with health authorities,
organization of hearings Coordination of the deficiency letters answers
Regulatory Affairs
RegulatoryMaintenance
RegulatoryIntelligence
Maintenance and renewals of registrations Management of variations
Continuous maintenance and development of the legislation know-how
ApartnerwhocaresChoosingGinsanaIBtotransformyourideaintorealitymeansyoucanrestassuredyourprojectwillbehandledwithutmostdiligence.Oursoundindustryexperience,flexibilityandinnovationensurethebenefitsofextensiveknow-howandprovensolutions.
Key staff Dr. Valter Gianesello DirectorofOperationsTelephone:+419161034 28Mobile:+4179500 75 [email protected]
ChristianvonDachHeadofIndustrialBusiness&PurchasingTelephone:+41916103205Mobile:[email protected] Dr. Alberto GaravaniIB Customer Support ManagerCoordinatorTelephone:+419161035 82Fax:[email protected]
Swiss excellence
Postal address:Ginsana SAPO Box 2656934 BioggioSwitzerland
Premises:Via MuliniCH-6934 Bioggio
Telephone: +41 91 610 31 11Fax: +41 91 610 32 09Email: [email protected]: www.ginsana-sa.com