Specialized Standalone or Integrated CMC Regulatory Solutions
The term pharmaceutical CMC stands for chemistry, manufacturing and controls, and is a fundamental requirement of any pharmaceutical application to health regulatory agencies.
EU & US CMC Experts
At Asphalion, we have a team of CMC experts with sound knowledge and experience in a wide range of pharmaceutical forms and types of products:
- Oral, injectable (including freeze-dried) and inhaled solid dosage forms
- Topic, oral, injectable and inhaled liquid dosage forms
- Topic, oral, injectable and inhaled semisolid dosage forms
We can either provide you a full integrated support (from lab to market) or a tailored support as per you specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products:
- Innovative (chemical and biological)
- Generics
- Biosimilars
- EU Hybrids / US 505b2
- Well-established use
- Herbal
Our EU & US CMC experts can actively collaborate with you on the following regulatory solutions:
Pharmaceutical Development
- Strategic development and Roadmaps – Integrated with Non-clinical & Clinical development
- Gap analysis at every stage of drug development
- Implementing and managing Quality by Design
- EU IMPD & US IND(A) – writing, review and/or updates
- Dossier writing, review and/or update – EU to US or US to EU
- Due-diligence of in-licensed dossiers
- Expert Reports
- Ad-hoc regulatory strategy
Registrations / Applications
- CTD Mod. 2 and 3 writing, review and/or updates for the EU and US, including:
- EU ASMF and US/RoW DMF.
- Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
- EU MAA (CP, DCP, MRP, NP)
- US IND(A), ANDA and NDA (505b1 and 505b2)
- Dossier gap analysis (Mod. 2.3 and Mod. 3.2.S, 3.2.P and 3.2.R)
- Due-diligence of in-licensing dossiers
- Expert support on responses to Deficiency Letters
- Expert Reports
Maintenance / Lifecycle Management
- CMC regulatory strategy
- CMC Regulatory compliance gap analysis
- Updating dossier sections – strategy, writing and review.
- Variations – strategy, writing, review and/or update of dossier
- Expert support on responses to Deficiency Letters
- CMC Expert Reports (including updates)
- Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) towards eCTD publishing
- Ad-hoc regulatory strategy
Do you need support or more information about the services? Contact us!
EU-FUNDED PROJECT | IN2SIGHT
IN2SIGHT is a project that fosters an unprecedented breakthrough in in-vivo optical imaging that will radically renew the biocompatibility tests of biomaterials. This technology will recast our thinking of biomaterial validation, allowing unprecedented quantitative and longitudinal analyses of the host inflammatory response to the implant.
WEBINAR | Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee Regulatory Perspectives
The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar featuring four expert speakers who will share regulatory perspectives from both sides of the Atlantic. One of them will be Marta Rayo Lunar, Regulatory and Scientific Affairs Director at Asphalion.
BIOSPAIN2021 | Roundtable
BioSpain, the largest country-based biotech event in Europe will be held in Pamplona and online this year.Our expert, Lidia Cánovas, General Manager, Regulatory Affairs at Asphalion, will be participating in a roundtable during the event together with four other experts.
AWARENESS | WORLD ALZHEIMER´S DAY
World Alzheimer’s Day was launched in 1994 to mark the 10th anniversary of Alzheimer’s Disease International (ADI) and World Alzheimer’s Month a decade ago, and both have grown significantly since then.
AWARENESS | WORLD PATIENT SAFETY DAY
World Patient Safety Day was established to enhance global understanding of patient safety, increase public engagement in the safety of health care and promote global actions to enhance patient safety and reduce patient harm.
