We gained a broad knowledge in Regulatory and Quality day to day extensive activity around the world.

We are always on the look-out of the perfect balance between client expectations and efficient solutions within regulatory compliance.


Audit and “Creating Compliant Solutions” for Quality & Regulatory compliance in Life Science Industry (20 year experience): “ To be more compliant but efficient”

Our motivation is to improve Health for patients. The main objective is to build bespoke solutions with our clients. We continuously update our knowledge in Current Regulations for creating Quality workflow process. We provide deliverables as solutions for innovating together.

Quality Systems

Updating / Creating Quality System “To be more efficient but compliant” (Drugs: ICH Q6-8-9-10-11 & ISO 9000 – US FDA 21CFR part 210-211; MDD: ISO 13485 & MDD 93/42 EEC amended 2007/47 EC - US FDA 21 CFR part 820- part 11)

Quality Audits and Preparation to Inspections

CAPA plans: Quality Audits (GMP & ISO 9001 - ISO 13485 & 21 CFR US FDA); Assessment for USA (21 CFR US FDA), CANADA, Taiwan (ROC) & Japan and Brazil (ANVISA) – Emerging Markets
Quality Plans: CAPA Assessment – Inspections and Audits preparation (SME concept)

Registration Dossiers for Marketing Authorization

  • Bioproducts: CMC regulatory Dossiers: Regulatory expert for writing and compiling files
  • Drugs & Bioproducts: (CMC parts – eCTDs – IMPD, IND, BLA)
  • Medical Devices: EC Mark & USA (510k & PMA IDA) & ROW MAA (Australia, Brazil, Canada (RIM), Japan, Taiwan)


Regulatory and Quality strategy for registration (MAA) and Reimbursement


Manufacturing (aseptic and sterile) facilities qualification


Our experience during 20 years in both small and majors organisations in the Medical and Pharmaceutical Industry gain us strong expertise and knowledge with wise maturity, expectations understanding, clients needs and good balance between know-how and bespoke deliverables.

How we work

We claim to be Client Specific and professional “Creating Compliant Solutions”

How we work

Simply reactive but more proactive

What are our day to day primary skills

We focus on great attention to details with strong interpersonal and communication skills

How we deal with our clients

We continuously improve our analytical and problem solving skills. We enhance our ability to adapt to new and multicultural environment and to apply acquired knowledge and skills sets to new situations.

How we improve

Continuously efforts are made to training and performing audit for continuous improvement

How we interact

We believe in strong cross functional skills to work with and support R&D and Marketing activities

Technical Assets

Technical assets are important in our field so we are constantly updating our knowledge in Scientific, Medical, Technical, Regulatory and Quality matters.

Multi Capability

  • Preparation of Inspections and Audits (Subject Matter Expert (SME)
  • Experience with a large variety of Combination products, Drugs and Medical Devices industry areas (Main Markets: EU, USA -21 CFR US FDA, Canada, Japan; Emerging markets: Brazil, Mexico, India, China, Indonesia)
  • Effective Management of Regulatory assessment, MAA registrations and deal with Regulatory Competent Authorities; Update and build core documentation: MAA (CMC parts - eCTDs, IMPDs, INDs, BLAs & EC files for MDD) including Design files, validation specifications, sterilization validation, packaging and labeling
  • Writing and Compiling files for registrations (MAA)
    • Medical Device Class I to III
    • CMC expert: Module 3 (Quality section of eCTD - M4AQ Drug substance and drug products); Drug substance synthesis - Drug product Manufacturing – Container closure

Bio-products experience list

Get in Touch

We want that your needs become our concerns.

Contact Info

Alcion Consulting
6, Quai des Chevillards(106/B)
M: +33(0) 6 22 48 67 73