Regulatory Affairs

Offered services:
- Obtaining, maintaining and renewing the Production of active / Finished medicinal substances authorizations;
- Support In document and workflow management for the SIS code acquisition;
- Setting up and submission of the type IA, IB, II, Line Extension variations, AIC transfer practices and Renewals;
- Chemical-pharmaceutical documentation Setup (Common Technical Document (CTD) - Module 3) and related Expert / Quality Overall Summary report;
- Clinical Expert Summary (Module 2.4 and 2.5) development;
- Regulatory, Technical and Scientific documentation development for the drugs registration and changes in existing records;
- Due diligence and gap analysis;
- NTA file conversion for the registration in Nees or eCTD format: preliminary assessment, filling the corresponding forms and its publishing;
- Development and preparation of the Nees / eCTD format dossier;
- Audits at manufacturing sites of active ingredients (API) and finished products in Italy and abroad.

NEWS - BIO CHEM S.R.L.

Echa has updated the list of suppliers of active substances or the list referred to in article 95 of
Harmonized standards for the sterilization of medical devices
Countdown to serialization
Legacy devices
Notification of production sites
Medical device and uni en iso 13485:2021
Estratto dagli highlights della riunione del comitato per la valutazione dei rischi in farmacovigila
Iso 14644-21 is released
Manual on borderline and classification in the community regulatory framework for medical devices (s
New allergens
Clinical trials: questions & answers document version 1.0 (05/2023)
Published the regulation 2023/707 amending the clp!
Aifa: istat rates update
Draft: who good manufacturing practices for excipients used in pharmaceutical 7 products
Self-certification and related contribution of 7%
Update on water in food supplements
Q13 continuous manufacturing of drug substances and drug products
Mdr - extension proposal
Update on nitrosamine impurities
Titanium dioxide, eu court annuls the regulation that considers it carcinogenic
Publishing service gazzetta ufficiale
Guidelines for the environmental labelling of packaging
Hazardous substances safety data sheets: new eu regulation 2020/878
Telematic management of applications and documents issued by the gmpmed office. new provisions start
Validity of authorizations as medical surgical aids for products intended for the disinfection of in
Medical devices, in the official gazette the legislative decrees for the adaptation of the national
Nsaids for systemic use: change request printed for use in pregnancy
Reports of suspected adverse reactions
Marketing of food supplements
Who publishes the new draft on chromatography
Ministry of health circular 4 march 2022 - ministerial indications for the placing on the market of
Self-certification and relative contribution of 7%
Medical device
Guidance on submission of marketing authorization/extension, ma variation and renewal applications,
Ema asks for checks on all the drugs on the market
59th afi symposium on 5-6-7 june at stand 83.
Aifa - increase in current rates
Method of submitting applications for marketing authorization, variations, renewals and asmf
Lists of scientific drug informers for the year 2018
Pay-back transaction agreements 2013-2015 (20/04/2018)
Brexit, ema publishes a guide to the industry in view of the uk exit from europe
Pharmaceutical excipients in the label, the guidelines reviewed by ce
Update: guideline on the excipients warnings to be included in the printed of homeopathic medicines
Lists of medical representatives medicines for the year 2016
Guideline on the excipients warnings to be included in the printed of homeopathic medicines (12/12/2
Aifa incoming single text changes "non-essential"
Medical devices, from spring 2017 they change the rules
COURSES

Our company offers courses from different content for different sectors.

REGULATIONS

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LOCATIONS

View all Bio Chem Srl headquarters in Naples, Rome, Milan


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SURVEY

From the following link will download the business service evaluation questionnaire regulators.

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