Regulatory Compliance and Consulting

The most modular, flexible and comprehensive solution covering Track & Trace compliance at all levels: enterprise (level 4), production plant, packaging line and warehouse, to ensure traceability compliance for EU-FMD, DSCSA and any other regulatory requirement for pharmaceutical products. A platfo...

PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client’s site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...

QPs are available to be listed on client MIA/MIA-IMPs and carry out batch release according to Directive 2001/83/EC (Human), Regulation (EU) No 536/2014 (clinical) and Regulation (EU) 2019/6 (veterinary).For GDP and distribution, we provide interim RP and RPi services to the pharmaceutical indust...

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary method...

Our team of experts will prepare necessary protocols incorporating all critical parameters


Process Validation:

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...

Our expertise offered in regulatory submissions and knowledgeable strategic skills in planning non-clinical testing programmes can reduce attrition rate and speed up the process.

JD Pharma Consultants Pvt.Ltd. is leading Pharmaceutical Project Consulting company offers services from design upto commissioning of Pharmaceutical project.Our services includes Plant layout design, HVAC, Civil, Electrical, mechenical, Clean room design & installation. We provide end to end solutions to o...

We provide regulatory and PV services, which can be tailored to suit individual client needs.
Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national he...

We can help you design and implement effective quality management systems that comply with current EU and UK GxP standards.

 An effective QMS will consist of all of the business processes, personnel responsibilities and standards including manuals, policies and procedures required to...

We work with our clients to ensure that the correct quality culture is embedded in their organisation by training the staff in the core principles of GMP, GDP, or other GxP industry practices.  When your employees understand the core principles of your quality system and the consequences of non-c...

Our pool of auditors have experience in a wide range of dosage forms and processes, medical devices, API, Excipient, laboratories, storage sites and service providers.  Each auditor is selected according to their expertise and experience and is assessed for suitability before engaging in a client ...

- Regulatory Affairs Consulting for FDA, EMA, MHRA, TGA, Health Canada, ANVISA, NMPA, PMDA, MCC, SAHPRA, and other NRAs - Pharmaceutical Drug Market Authorization, Biotech, Pharmacovigilance, Pre-Sub, IND, ANDA, NDA, BLA, Establishment Registration - QA Pharma, GMP, GCP, GLP, GDP pre-audit -...

Pharmaceutical Project Management 1. Gap Analysis (Audit)/Upgradation (Brown Field)/Expansion 2. New Pharmaceutical Manufacturing Project Designing, URS, Room Data Sheets & BOQs. 3. Project Documentation (SOPs) 4. Co-ordination, Supervision & imp...

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Quasaar does not see itself as "processing office" of service contracts.

As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
Our expertise includes i.a. following topics: ...