- Establishing, reviewing, updating the Quality Management Systems for cGMP / GDP requirements as per ICH, EU, USFDA 21 CFR and ISO 9000 requirements.
- Design, review and execute analytical validations, process validations.
- Validations of automated systems, such as SAP, Trackwise, EDMS, RIMS as per GAMP guidelines.
- GMP trainings / workshops
- Guidance in writing user’s guide and SOPs
- Tech transfers of API and drug product processes
- Performing due diligence / gap analysis / risk assessment / qualifications for:
- Starting materials, intermediates, active pharmaceutical ingredient manufacturers,
- Finished dosage form manufacturers,
- Research and analytical laboratories,
- Wholesale dealers & distribution centre.
- Pre-audit to prepare for health authority inspections and supporting in the preparations of the responses.
- Routine audits for QMS as part of ongoing cGMP compliance reviews
- Preparing the regulatory strategies for global registrations, including emerging markets.
- Preparing / reviewing ASMF/ DMFs for APIs (CEP, USFDA, ANVISA, SFDA, Korea, TGA etc.).
- Preparing / reviewing ANDAs / Dossiers of drug products (oral applications) for US / EU registrations.
- Supporting eCTD reviews and submissions.
- Trainings regarding the regulatory processes like change management, choice of starting materials, impurities including elemental impurities & residual solvents, good quality dossiers, life cycle management and applicable ICH guidelines, EU & US registration procedures etc.
DADA Consultancy BV / ADOH B.V, Nijmegen, The Netherlands
DADA consultancy B.V. is a highly specialised and independent consultancy agency in international regulatory affairs of human and veterinary medicinal products across Globe. Specialised in European and USA registrations.
ADOH B.V. is a Dutch pharmaceutical manufacturer and service provider that is part of the DADA Consultancy BV.
ADOH is providing the Marketing Authorisation Services for non-European as well as for European pharmaceutical companies to use ADOH (temporarily) as the formal marketing authorisation holder for their medicinal products.
EU Batch Release, QP Services and Pharmacovigilance services.https://www.dada.nl/
Pharmaffiliates Analytics & Synthetics (P) Ltd., Punchkula, India
Pharmaffiliates Analytics and Synthetics P. Ltd., an integrated Contract Research Organization (CRO) is a gigantic name in the global market, which offers services to Pharmaceutical industry, Biotechnology industry, API manufacturers, Bulk drug suppliers, clinical CROs, Research institutes and other allied industries.
Pharmaffiliates main focus is on Synthetic Research, Analytical Research, NDDS and Regulatory Consulting Synthesis and characterization of various impurities and metabolites for pharmacopoeial as well non-pharmacopoeial products, for qualitative and quantitative analytical use
- Identification of Unknown Impurities and establishing the Impurity Profiling
- Analytical Method Development, Validation and method Transfer meeting ICH, ANVISA requirements
- Specific analysis like LCMS/MS, NMR, XRD, ICP MS
- Stability Studies
- Extractables & Leachables studies
- Forced Degradation Studies
- Trace Metal Analysis
Food Safety Experts / Food recall NL, Holten, The Netherlands
At Food Safety Experts, we help you to maximise your impact and deliver exceptional results by sharing our knowledge and tools based on industry-wide best practices in Quality and Food safety, to deliver good quality and safe food products all the time and make a difference compared to others.
We have long-standing track record in the international food industry and have worked for and with all the large players in the food industry. Next to this we have a wide experience in working with a vast amount of SME’s in all areas of the food industry. Our experience includes fruit & vegetables, nuts & spices, meat, fish, dairy, beverages, baking, bio-technology, infant nutrition, pharmaceuticals. All of this includes fresh, chilled, frozen, ambient stable and ready to eat foods. Together we have audited more than 400 plants globally, from this we have gained a lot of experience and useful tools and information, which we will share with you!
At Food Safety Experts, our vision is a world where safe food is a given for everyone. Our mission is to enable QA and Food Safety professionals to make a difference towards improving food safety. We do this by actively sharing our knowledge and tools and by creating a global community.https://www.foodsafety-experts.com