Key Achievements and Global Regulatory Impact
Techsol’s regulatory team has a proven track record of resolving complex clinical hold issues, enabling the initiation of critical Phase 1 and Phase 3 trials across therapeutic areas including Cardiovascular, Antiviral, Vaccines, Ophthalmology, Oncology, Neurology: anti-migraine, anti-epileptic, Alzheimer’s, Parkinson’s, and antidepressants schizophrenia. Also, we have successfully submitted multiple INDs and Phase 2 protocols for start-ups and mid-sized companies, including novel delivery technologies like combination products, Cell Therapy, Gene Therapy, and Rare Diseases.
Key Achievements and Global Regulatory Impact
- Resolved clinical hold issues to enable:
- Phase 3 trial initiation for schizophrenia.
- Phase 1 studies for a start-up and a leading ocular company.
- Successfully submitted:
- IND and Phase 2 protocol for a start-up.
- IND for a mid-sized company using microneedle array technology.
- Led regulatory meetings including:
- 8 Pre-IND, 3 End-of-Phase 2 (EOP2), and multiple INTERACT meetings with FDA.
- 4 Scientific Advice meetings with EMA.
- 50+ PIND meetings (FDA), 16 with EMA, and multiple meetings with COFEPRIS, ISP, ANVISA, DIGEMID, PMDA, KFDA, GCC (Saudi Arabia & MoH), and NMPA.
- Assisted clients with:
- NDA re-submissions following Complete Response Letters (CRLs).
- IND preparation and submissions (22 INDs filed overall, including 5 in neuroscience and 3 in oncology).
- Obtained critical regulatory designations:
- Approval for a New Chemical Entity (NCE) with DCGI, India
- RMAT for two regenerative medicine products.
- Fast Track and QIDP status for seven antibiotic drugs under the GAIN Act.
- 12 Orphan Drug Designations across neurological, ocular, and rare diseases (FDA and EMA).
- Developed and executed a 505(b)(2) regulatory strategy for an IV formulation of an MS drug:
- Held PIND meeting with FDA, drafted BE protocol, obtained orphan designation, and supported IND/NDA filings.
- Successfully negotiated regulatory approvals:
- 1 BLA, 2 NDAs, 3 ANDAs with FDA.
- 2 biosimilar marketing authorizations with COFEPRIS, DIGEMID, ISP, and ANVISA.
- Engaged with global agencies to secure recognition of "unmet medical need" for an antibiotic (FDA, EMA, NMPA, SAHPRA, ANVISA).
- Provided regulatory strategy for stem cell and regenerative therapies targeting:
- Brain trauma, wound healing, and arthritis (led INTERACT meetings with FDA).
- Built and implemented quality infrastructure:
- Established Quality Assurance (QA) systems, Quality Control (QC) procedures, and SOPs for product development and release for multiple clients.
- Audited CMO facilities and clinical sites (including for the COVAXIN pivotal trial in India) to ensure regulatory compliance.
- Developed EU-compliant Pharmacovigilance systems and QPPV activities.
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